Professional Documents
Culture Documents
200
180
160
140
120
100
80
60
40
20
0
Craniomaxillofacial
What makes Iliac Crest Bone Graft (ICBG) the gold standard?
Spine
Scaffold
Orthobiologics
Surgical Products
20
07
20
06
20
05
20
04
20
03
20
02
20
01
20
00
19
99
19
98
19
96
The #1 Synthetic
Bone Graft1
Interventional Spine
Year
Navigation
Currently, there are over 180 510(k) clearances for orthopaedic bone graft
products. Because of the vast number of products available, it is often
difficult for surgeons to assess the best choices for bone grafting.5
Epstein, N.E., An analysis of Noninstrumented Posterolateral Lunbar Fusions Performed
in Predominantly Geriatric Patients Using Lamina Autograft and Beta-Tricalcium Phosphate. The Spine Journal, February 2008.
Study Design:
Prospective; 60 patients using Noninstrumented PLF; Average age = 70 years
Outcome Measures:
CT scans - Fusion assessment; Dynamic X-rays; Fusion assessed separately by 2 neuroradiologists blinded to the treatment; Post-operative outcomes using SF-36; 3, 6, 12, and
24 months follow up
Results:
Successful fusion in 85% of patients (51/60) when judged by CT and F/E
Epstein, N.E., Beta-Tricalcium Phosphate: Observation of Use in 100 Posterolateral
Lumbar Instrumented Fusions. The Spine Journal, June 2009.
Study Design:
Prospective; 100 patients with lumbar spinal stenosis; Multisegment laminectomies (avg. 3.6
segments) and one segment (78 patients) or two segment (22 patients) instrumented PLF
Outcome Measures:
Dynamic X-rays; 2D-CT Scans; Post-operative outcomes using SF-36; Fusion assessed
separately by 2 neuroradiologists blinded to the treatment; 3, 4.5, 6, and 12 month follow
up with a minimum of 2.5 years and maximum of 5.0 years (avg. 3.1 years)
Results:
Successful fusion in 95% of patients (95/100) when judged by CT and Dynamic X-ray
The vast majority of products have no human clinical data to support their use.
Ultimately, human clinical data should be used to select a bone graft.
5
Endoscopy
1 - Millennium Research Group: US Markets for Orthopedic Biomaterials 2010.
2 - Peter Ullrich Jr., Autograft: The Patient's Own Bone. Published in 9/8/99 and updated on 11/25/09 on Spine Universe.
3 - Bellincampi, L., Clineff, T., Erbe, E., Osteoinductivity of Vitoss with Isologous Bone Marrow in Urist Rat Pouch Model.
Society for Biomaterials, Tampa, FL, April 24-27, 2002 (Podium).
4 - www.fda.gov, MQV products, November 2007.
5 - The Evolving Role of Bone Graft Substitutes. American Academy of Orthopaedic Surgeons 77th Annual Meeting,
March 9-13, 2010.
6 - Stryker Orthobiologics Internal Sales Data, July 2011.
7 - Vitoss Bibliography, P/N 5606-0117 Rev. 00, 2010.
8 - Motomiya, M., et al., Effect of Hydroxyapatite Porous Characteristics on Healing Outcomes in Rabbit Posterolateral
Spinal Fusion Model. European Spine Journal, 2007; 16: 2215-2224.
9 - Orthovita Test Report P/N 1070-0008R.
10 - Orthovita Test Report P/N 1050-0003R.
11 - Characteristics of Vitoss BA Product.
12 - Hench, L.L., Splinter, R.J., and Allen, W.C., Bonding Mechanisms at the Interface of Ceramic Prosthetic Materials.
Journal of Biomedical Materials Research, 1971; 2(1): 117-141.
13 - Hench, L.L., Paschall, H.A., Direct Chemical Bond of Bioactive Glass-Ceramic Materials to Bone and Muscle.
Journal of Biomedical Materials Research, 1973; 4: 25-42.
14 - Gross, U., The Interface of Various Glasses and Glass Ceramics with a Bony Implantation Bed. Journal of Biomedical
Materials Research, 1985; 19: 251-271.
15 - Sanders, D.M., Hench, L.L., Mechanisms of Glass Corrosion. Journal of American Ceramic Society. 1973; 56(7): 373-377.
16 - Hench, L.L., Characterization of Glass Corrosion and Durability. Journal of Non-Crystalline Solids, 1975; 19: 27-39.
17 - Ogino, M., Hench, L.L., Formation of Calcium Phosphate Films on Silicate Glasses. Journal of Non-Crystalline Solids,
1980; 38 and 39: 673-678.
18 - Vrouwenvelder, W.C.A., Histological and Biochemical Evaluation of Osteoblasts Cultured on Bioactive Glass,
Hydroxyapatite, Titanium Alloy, and Stainless Steel. Journal of Biomedical Materials Research, 1993 Apr; 27(4): 465-75.
19 - Hench, L.L., The Story of Bioglass. Journal of Materials Science: Materials in Medicine, 2006 Nov; 17(11): 967-78.
20 - Oonishi, H., et al., Particulate Bioglass Compared with Hydroxyapatite as a Bone Graft Substitute. Clinical Orthopaedics
and Related Research, 1997 Jan; 334: 316-25.
21 - Xynos, I.D., Edgar, A.J., Buttery, L.D.K., Hench, L.L., and Polak, J.M., Ionic Products of Bioactive Glass Dissolution Increase
Proliferation of Human Osteoblasts and Induce Insulin-like Growth Factor II mRNA Expression and Protein Synthesis.
Biochemical and Biophysical Research Communications, 2000 September 24; 276(2): 461-5.
22 - Anker et al, Ultraporous Beta-Tricalcium Phosphate is Well Incorporated in Small Cavitary Defects. Clinical
Orthopaedics and Related Research, 2005 May; 434: 251-7.
23 - Brown, LS, Darmoc, MM, Owsiany, RS, Clineff, TD, Improvements in Healing with a Bioactive Bone Graft
Substitute in a Canine Metaphyseal Defect. 55th Annual Meeting of the Orthopaedic Research Society, 2009.
24 - Havener, MB, Clineff, TD, Darmoc, MM, Brown, LS, Owsiany, R, A Comparative Study of Synthetic Bone Graft
Substitutes in a Canine Metaphyseal Defect. 54th Annual Meeting of the Orthopaedic Research Society, 2008.
25 - Marx, J., Bone Marrow: A Validated Biological Driver for Bone Regeneration, White Paper.
26 - Muschler, G.F., Nakamoto, C., Griffith, L.G., Engineering Principles of Clinical Cell-Based Tissue Engineering.
Journal of Bone and Joint Surgery, 2004; 86(7): 1541.
27 - Curylo, L.J., et al., Augmentation of Spinal Arthrodesis With Autologous Bone Marrow in a Rabbit Posterolateral Spine
Fusion Model. Spine, 1999 March 1, 24(5 ): 434-8.
28 - Deakin, D.E., Bannister, G.C., Graft Incorporation After Acetabular and Femoral Impaction Grafting With Washed
Irradiated Allograft and Autologous Marrow. The Journal of Arthroplasty, 2007 January; 22(1): 89-94.
29 - Kim, K.J., et al., Effect of Bone Marrow Grafting on the Titanium Porous-Coated Implant in Bilateral Total Knee
Arthroplasty. Acta Orthopaedica, 2007 February; 78(1): 116-22.
Communications
Imaging
Signal
EMS Equipment
Cells
Scaffold
Autograft (ICBG)
A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular
product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be
trained in the use of any particular product before using it in surgery. The information presented in this brochure is
intended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructions
before using any Stryker product. Products may not be available in all markets. Product availability is subject to the
regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have
questions about the availability of Stryker products in your area.
Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks
or service marks: Imbibe, Stryker, Vitoss. All other trademarks are trademarks of their respective owners or holders.
Literature Number: 5701-0000 Rev. 00
AQ/LW 08/11
Copyright 2011 Stryker
Printed in USA
Vertebral Body
(via pedicle)
Iliac Crest (PSIS, ASIS)
Calcaneus
200
180
160
140
120
100
80
60
40
20
0
Craniomaxillofacial
What makes Iliac Crest Bone Graft (ICBG) the gold standard?
Spine
Scaffold
Orthobiologics
Surgical Products
20
07
20
06
20
05
20
04
20
03
20
02
20
01
20
00
19
99
19
98
19
96
The #1 Synthetic
Bone Graft1
Interventional Spine
Year
Navigation
Currently, there are over 180 510(k) clearances for orthopaedic bone graft
products. Because of the vast number of products available, it is often
difficult for surgeons to assess the best choices for bone grafting.5
Epstein, N.E., An Analysis of Noninstrumented Posterolateral Lumbar Fusions Performed
in Predominantly Geriatric Patients Using Lamina Autograft and Beta-Tricalcium Phosphate. The Spine Journal, February 2008.
Study Design:
Prospective; 60 patients using Noninstrumented PLF; Average age = 70 years
Outcome Measures:
CT scans - Fusion assessment; Dynamic X-rays; Fusion assessed separately by 2 neuroradiologists blinded to the treatment; Post-operative outcomes using SF-36; 3, 6, 12, and
24 months follow up
Results:
Successful fusion in 85% of patients (51/60) when judged by CT and F/E
Epstein, N.E., Beta-Tricalcium Phosphate: Observation of Use in 100 Posterolateral
Lumbar Instrumented Fusions. The Spine Journal, June 2009.
Study Design:
Prospective; 100 patients with lumbar spinal stenosis; Multisegment laminectomies (avg. 3.6
segments) and one segment (78 patients) or two segment (22 patients) instrumented PLF
Outcome Measures:
Dynamic X-rays; 2D-CT Scans; Post-operative outcomes using SF-36; Fusion assessed
separately by 2 neuroradiologists blinded to the treatment; 3, 4.5, 6, and 12 month follow
up with a minimum of 2.5 years and maximum of 5.0 years (avg. 3.1 years)
Results:
Successful fusion in 95% of patients (95/100) when judged by CT and Dynamic X-ray
The vast majority of products have no human clinical data to support their use.
Ultimately, human clinical data should be used to select a bone graft.
5
Endoscopy
1 - Millennium Research Group: US Markets for Orthopedic Biomaterials 2010.
2 - Peter Ullrich Jr., Autograft: The Patient's Own Bone. Published in 9/8/99 and updated on 11/25/09 on Spine Universe.
3 - Bellincampi, L., Clineff, T., Erbe, E., Osteoinductivity of Vitoss with Isologous Bone Marrow in Urist Rat Pouch Model.
Society for Biomaterials, Tampa, FL, April 24-27, 2002 (Podium).
4 - www.fda.gov, MQV products, November 2007.
5 - The Evolving Role of Bone Graft Substitutes. American Academy of Orthopaedic Surgeons 77th Annual Meeting,
March 9-13, 2010.
6 - Stryker Orthobiologics Internal Sales Data, July 2011.
7 - Vitoss Bibliography, P/N 5606-0117 Rev. 00, 2010.
8 - Motomiya, M., et al., Effect of Hydroxyapatite Porous Characteristics on Healing Outcomes in Rabbit Posterolateral
Spinal Fusion Model. European Spine Journal, 2007; 16: 2215-2224.
9 - Orthovita Test Report P/N 1070-0008R.
10 - Orthovita Test Report P/N 1050-0003R.
11 - Characteristics of Vitoss BA Product.
12 - Hench, L.L., Splinter, R.J., and Allen, W.C., Bonding Mechanisms at the Interface of Ceramic Prosthetic Materials.
Journal of Biomedical Materials Research, 1971; 2(1): 117-141.
13 - Hench, L.L., Paschall, H.A., Direct Chemical Bond of Bioactive Glass-Ceramic Materials to Bone and Muscle.
Journal of Biomedical Materials Research, 1973; 4: 25-42.
14 - Gross, U., The Interface of Various Glasses and Glass Ceramics with a Bony Implantation Bed. Journal of Biomedical
Materials Research, 1985; 19: 251-271.
15 - Sanders, D.M., Hench, L.L., Mechanisms of Glass Corrosion. Journal of American Ceramic Society. 1973; 56(7): 373-377.
16 - Hench, L.L., Characterization of Glass Corrosion and Durability. Journal of Non-Crystalline Solids, 1975; 19: 27-39.
17 - Ogino, M., Hench, L.L., Formation of Calcium Phosphate Films on Silicate Glasses. Journal of Non-Crystalline Solids,
1980; 38 and 39: 673-678.
18 - Vrouwenvelder, W.C.A., Histological and Biochemical Evaluation of Osteoblasts Cultured on Bioactive Glass,
Hydroxyapatite, Titanium Alloy, and Stainless Steel. Journal of Biomedical Materials Research, 1993 Apr; 27(4): 465-75.
19 - Hench, L.L., The Story of Bioglass. Journal of Materials Science: Materials in Medicine, 2006 Nov; 17(11): 967-78.
20 - Oonishi, H., et al., Particulate Bioglass Compared with Hydroxyapatite as a Bone Graft Substitute. Clinical Orthopaedics
and Related Research, 1997 Jan; 334: 316-25.
21 - Xynos, I.D., Edgar, A.J., Buttery, L.D.K., Hench, L.L., and Polak, J.M., Ionic Products of Bioactive Glass Dissolution Increase
Proliferation of Human Osteoblasts and Induce Insulin-like Growth Factor II mRNA Expression and Protein Synthesis.
Biochemical and Biophysical Research Communications, 2000 September 24; 276(2): 461-5.
22 - Anker et al, Ultraporous Beta-Tricalcium Phosphate is Well Incorporated in Small Cavitary Defects. Clinical
Orthopaedics and Related Research, 2005 May; 434: 251-7.
23 - Brown, LS, Darmoc, MM, Owsiany, RS, Clineff, TD, Improvements in Healing with a Bioactive Bone Graft
Substitute in a Canine Metaphyseal Defect. 55th Annual Meeting of the Orthopaedic Research Society, 2009.
24 - Havener, MB, Clineff, TD, Darmoc, MM, Brown, LS, Owsiany, R, A Comparative Study of Synthetic Bone Graft
Substitutes in a Canine Metaphyseal Defect. 54th Annual Meeting of the Orthopaedic Research Society, 2008.
25 - Marx, J., Bone Marrow: A Validated Biological Driver for Bone Regeneration, White Paper.
26 - Muschler, G.F., Nakamoto, C., Griffith, L.G., Engineering Principles of Clinical Cell-Based Tissue Engineering.
Journal of Bone and Joint Surgery, 2004; 86(7): 1541.
27 - Curylo, L.J., et al., Augmentation of Spinal Arthrodesis With Autologous Bone Marrow in a Rabbit Posterolateral Spine
Fusion Model. Spine, 1999 March 1, 24(5 ): 434-8.
28 - Deakin, D.E., Bannister, G.C., Graft Incorporation After Acetabular and Femoral Impaction Grafting With Washed
Irradiated Allograft and Autologous Marrow. The Journal of Arthroplasty, 2007 January; 22(1): 89-94.
29 - Kim, K.J., et al., Effect of Bone Marrow Grafting on the Titanium Porous-Coated Implant in Bilateral Total Knee
Arthroplasty. Acta Orthopaedica, 2007 February; 78(1): 116-22.
Communications
Imaging
Signal
EMS Equipment
Cells
Scaffold
Autograft (ICBG)
A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular
product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be
trained in the use of any particular product before using it in surgery. The information presented in this brochure is
intended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructions
before using any Stryker product. Products may not be available in all markets. Product availability is subject to the
regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have
questions about the availability of Stryker products in your area.
Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks
or service marks: Imbibe, Stryker, Vitoss. All other trademarks are trademarks of their respective owners or holders.
Literature Number: 5701-0000 Rev. 00
AQ/LW 08/11
Copyright 2011 Stryker
Printed in USA
Vertebral Body
(via pedicle)
Iliac Crest (PSIS, ASIS)
Calcaneus
200
180
160
140
120
100
80
60
40
20
0
Craniomaxillofacial
What makes Iliac Crest Bone Graft (ICBG) the gold standard?
Spine
Scaffold
Orthobiologics
Surgical Products
20
07
20
06
20
05
20
04
20
03
20
02
20
01
20
00
19
99
19
98
19
96
The #1 Synthetic
Bone Graft1
Interventional Spine
Year
Navigation
Currently, there are over 180 510(k) clearances for orthopaedic bone graft
products. Because of the vast number of products available, it is often
difficult for surgeons to assess the best choices for bone grafting.5
Epstein, N.E., An Analysis of Noninstrumented Posterolateral Lumbar Fusions Performed
in Predominantly Geriatric Patients Using Lamina Autograft and Beta-Tricalcium Phosphate. The Spine Journal, February 2008.
Study Design:
Prospective; 60 patients using Noninstrumented PLF; Average age = 70 years
Outcome Measures:
CT scans - Fusion assessment; Dynamic X-rays; Fusion assessed separately by 2 neuroradiologists blinded to the treatment; Post-operative outcomes using SF-36; 3, 6, 12, and
24 months follow up
Results:
Successful fusion in 85% of patients (51/60) when judged by CT and F/E
Epstein, N.E., Beta-Tricalcium Phosphate: Observation of Use in 100 Posterolateral
Lumbar Instrumented Fusions. The Spine Journal, June 2009.
Study Design:
Prospective; 100 patients with lumbar spinal stenosis; Multisegment laminectomies (avg. 3.6
segments) and one segment (78 patients) or two segment (22 patients) instrumented PLF
Outcome Measures:
Dynamic X-rays; 2D-CT Scans; Post-operative outcomes using SF-36; Fusion assessed
separately by 2 neuroradiologists blinded to the treatment; 3, 4.5, 6, and 12 month follow
up with a minimum of 2.5 years and maximum of 5.0 years (avg. 3.1 years)
Results:
Successful fusion in 95% of patients (95/100) when judged by CT and Dynamic X-ray
The vast majority of products have no human clinical data to support their use.
Ultimately, human clinical data should be used to select a bone graft.
5
Endoscopy
1 - Millennium Research Group: US Markets for Orthopedic Biomaterials 2010.
2 - Peter Ullrich Jr., Autograft: The Patient's Own Bone. Published in 9/8/99 and updated on 11/25/09 on Spine Universe.
3 - Bellincampi, L., Clineff, T., Erbe, E., Osteoinductivity of Vitoss with Isologous Bone Marrow in Urist Rat Pouch Model.
Society for Biomaterials, Tampa, FL, April 24-27, 2002 (Podium).
4 - www.fda.gov, MQV products, November 2007.
5 - The Evolving Role of Bone Graft Substitutes. American Academy of Orthopaedic Surgeons 77th Annual Meeting,
March 9-13, 2010.
6 - Stryker Orthobiologics Internal Sales Data, July 2011.
7 - Vitoss Bibliography, P/N 5606-0117 Rev. 00, 2010.
8 - Motomiya, M., et al., Effect of Hydroxyapatite Porous Characteristics on Healing Outcomes in Rabbit Posterolateral
Spinal Fusion Model. European Spine Journal, 2007; 16: 2215-2224.
9 - Orthovita Test Report P/N 1070-0008R.
10 - Orthovita Test Report P/N 1050-0003R.
11 - Characteristics of Vitoss BA Product.
12 - Hench, L.L., Splinter, R.J., and Allen, W.C., Bonding Mechanisms at the Interface of Ceramic Prosthetic Materials.
Journal of Biomedical Materials Research, 1971; 2(1): 117-141.
13 - Hench, L.L., Paschall, H.A., Direct Chemical Bond of Bioactive Glass-Ceramic Materials to Bone and Muscle.
Journal of Biomedical Materials Research, 1973; 4: 25-42.
14 - Gross, U., The Interface of Various Glasses and Glass Ceramics with a Bony Implantation Bed. Journal of Biomedical
Materials Research, 1985; 19: 251-271.
15 - Sanders, D.M., Hench, L.L., Mechanisms of Glass Corrosion. Journal of American Ceramic Society. 1973; 56(7): 373-377.
16 - Hench, L.L., Characterization of Glass Corrosion and Durability. Journal of Non-Crystalline Solids, 1975; 19: 27-39.
17 - Ogino, M., Hench, L.L., Formation of Calcium Phosphate Films on Silicate Glasses. Journal of Non-Crystalline Solids,
1980; 38 and 39: 673-678.
18 - Vrouwenvelder, W.C.A., Histological and Biochemical Evaluation of Osteoblasts Cultured on Bioactive Glass,
Hydroxyapatite, Titanium Alloy, and Stainless Steel. Journal of Biomedical Materials Research, 1993 Apr; 27(4): 465-75.
19 - Hench, L.L., The Story of Bioglass. Journal of Materials Science: Materials in Medicine, 2006 Nov; 17(11): 967-78.
20 - Oonishi, H., et al., Particulate Bioglass Compared with Hydroxyapatite as a Bone Graft Substitute. Clinical Orthopaedics
and Related Research, 1997 Jan; 334: 316-25.
21 - Xynos, I.D., Edgar, A.J., Buttery, L.D.K., Hench, L.L., and Polak, J.M., Ionic Products of Bioactive Glass Dissolution Increase
Proliferation of Human Osteoblasts and Induce Insulin-like Growth Factor II mRNA Expression and Protein Synthesis.
Biochemical and Biophysical Research Communications, 2000 September 24; 276(2): 461-5.
22 - Anker et al, Ultraporous Beta-Tricalcium Phosphate is Well Incorporated in Small Cavitary Defects. Clinical
Orthopaedics and Related Research, 2005 May; 434: 251-7.
23 - Brown, LS, Darmoc, MM, Owsiany, RS, Clineff, TD, Improvements in Healing with a Bioactive Bone Graft
Substitute in a Canine Metaphyseal Defect. 55th Annual Meeting of the Orthopaedic Research Society, 2009.
24 - Havener, MB, Clineff, TD, Darmoc, MM, Brown, LS, Owsiany, R, A Comparative Study of Synthetic Bone Graft
Substitutes in a Canine Metaphyseal Defect. 54th Annual Meeting of the Orthopaedic Research Society, 2008.
25 - Marx, J., Bone Marrow: A Validated Biological Driver for Bone Regeneration, White Paper.
26 - Muschler, G.F., Nakamoto, C., Griffith, L.G., Engineering Principles of Clinical Cell-Based Tissue Engineering.
Journal of Bone and Joint Surgery, 2004; 86(7): 1541.
27 - Curylo, L.J., et al., Augmentation of Spinal Arthrodesis With Autologous Bone Marrow in a Rabbit Posterolateral Spine
Fusion Model. Spine, 1999 March 1, 24(5 ): 434-8.
28 - Deakin, D.E., Bannister, G.C., Graft Incorporation After Acetabular and Femoral Impaction Grafting With Washed
Irradiated Allograft and Autologous Marrow. The Journal of Arthroplasty, 2007 January; 22(1): 89-94.
29 - Kim, K.J., et al., Effect of Bone Marrow Grafting on the Titanium Porous-Coated Implant in Bilateral Total Knee
Arthroplasty. Acta Orthopaedica, 2007 February; 78(1): 116-22.
Communications
Imaging
Signal
EMS Equipment
Cells
Scaffold
Autograft (ICBG)
A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular
product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be
trained in the use of any particular product before using it in surgery. The information presented in this brochure is
intended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructions
before using any Stryker product. Products may not be available in all markets. Product availability is subject to the
regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have
questions about the availability of Stryker products in your area.
Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks
or service marks: Imbibe, Stryker, Vitoss. All other trademarks are trademarks of their respective owners or holders.
Literature Number: 5701-0000 Rev. 00
AQ/LW 08/11
Copyright 2011 Stryker
Printed in USA
Vertebral Body
(via pedicle)
Iliac Crest (PSIS, ASIS)
Calcaneus
3 Weeks
6 Weeks
12 Weeks
52 Weeks
VITOSS
Morsels
Foam Pack*
Imbibe
1.2cc
sponge
15cc Macro
(2102-0020)
golf ball
other
scaffolds
porosity
ActiFuse
2.5cc
5cc
30cc Macro
(2102-0021)
(2102-1405)
(2102-1605) BA
(2102-2105) BA
10cc
(2102-1410)
(2102-1610) BA
(2102-2110) BA
ProOsteon
structure
(2102-1401)
(2102-1601) BA
(2102-2101) BA2X
(2102-1402)
(2102-1602) BA
(2102-2102) BA
VITOSS
1.2cc Blocks
(2102-0013)
10cc Blocks
(2102-0006)
MasterGraft
Comparison of VITOSS to ActiFuse, ProOsteon, and MasterGraft in a canine metaphyseal study in order to radiologically compare
healing at 3, 6, 12, 24, and 52 weeks. A 10mm x 22mm drill defect was created in the proximal humerus and lled with 2cc of bone graft.24
bioactivity11
Bioactive glass has shown positive bondingto-bone properties.12-14 Upon implantation, the
ionic constituents (Si+, Na+, Ca2+) of bioactive
glass are released into the surrounding environment and react with the bodily fluids.18-21 This
reaction produces the deposition of a thin layer
of physiologic CaP at its surface, thus attracting
osteoblasts to the layer to create a matrix that
promotes an osteostimulatory effect.12-18 This may
lead to the bonding of new bone to the scaffold.
25
chemistry
VITOSS BA has a unique porosity, structure, bioactivity, and chemistry to drive the 3-D
regeneration of bone and potentially increase the rate of healing as shown in an animal study.23
There are over 150 references supporting the use of bone marrow for grafting.25
Less morbidity
25 x 100 x 4mm
10cc (2102-1100)
25 x 100 x 4mm (BA)
10cc (2102-1500)
25 x 100 x 8mm
20cc (2102-1120)
25 x 100 x 8mm (BA)
20cc (2102-1520)
25 x 240 x 4mm
24cc (2102-1101)
25 x 50 x 4mm
5cc (2102-1105)
25 x 50 x 4mm (BA)
5cc (2102-1505)
90% incorporation of graft with BMA was achieved during impaction grafting
versus 40% for controls (historical).
The addition of autologous marrow is a cheap and highly effective way of
achieving graft incorporation.28
25 x 50 x 8mm
10cc (2102-1110)
25 x 50 x 8mm (BA)
10cc (2102-1510)
75 x 100 x 4mm
30cc (2102-1130)
10cc
(2105-0010)
20cc
(2105-0020)
30cc
(2105-0030)
Canisters
Vitoss Canisters offer the handling and delivery
of Vitoss Morsels with the use of bone marrow
aspirate or blood. It is a closed system designed to minimize handling and exposure to potential contaminants.
5cc Micro
(2102-0026)
5cc Standard
(2102-0030)
Foam Strip*
Syringes
10cc Micro
(2102-0027)
10cc Standard
(2102-0031)
15cc Micro
(2102-0028)
Needles
11 gauge x 4 inch
(2090-0027)
11 gauge x 6 inch
(2090-0028)
8 gauge x 6 inch
(2090-0029)
8 gauge x 8 inch
(2090-0047)
Fenestrated
8 gauge x 6 inch
(2090-0030)
15cc Standard
(2102-0032)
30cc Micro
(2102-0029)
30cc Standard
(2102-0033)
Bullet-tip
Sharp-tip
Cups
Foam Flow
5cc
(2102-1305)
10cc
(2102-1310)
3 Weeks
6 Weeks
12 Weeks
52 Weeks
VITOSS
Morsels
Foam Pack*
Imbibe
1.2cc
sponge
15cc Macro
(2102-0020)
golf ball
other
scaffolds
porosity
ActiFuse
2.5cc
5cc
30cc Macro
(2102-0021)
(2102-1405)
(2102-1605) BA
(2102-2105) BA
10cc
(2102-1410)
(2102-1610) BA
(2102-2110) BA
ProOsteon
structure
(2102-1401)
(2102-1601) BA
(2102-2101) BA2X
(2102-1402)
(2102-1602) BA
(2102-2102) BA
VITOSS
1.2cc Blocks
(2102-0013)
10cc Blocks
(2102-0006)
MasterGraft
Comparison of VITOSS to ActiFuse, ProOsteon, and MasterGraft in a canine metaphyseal study in order to radiologically compare
healing at 3, 6, 12, 24, and 52 weeks. A 10mm x 22mm drill defect was created in the proximal humerus and lled with 2cc of bone graft.24
bioactivity11
Bioactive glass has shown positive bondingto-bone properties.12-14 Upon implantation, the
ionic constituents (Si+, Na+, Ca2+) of bioactive
glass are released into the surrounding environment and react with the bodily fluids.18-21 This
reaction produces the deposition of a thin layer
of physiologic CaP at its surface, thus attracting
osteoblasts to the layer to create a matrix that
promotes an osteostimulatory effect.12-18 This may
lead to the bonding of new bone to the scaffold.
25
chemistry
VITOSS BA has a unique porosity, structure, bioactivity, and chemistry to drive the 3-D
regeneration of bone and potentially increase the rate of healing as shown in an animal study.23
There are over 150 references supporting the use of bone marrow for grafting.25
Less morbidity
25 x 100 x 4mm
10cc (2102-1100)
25 x 100 x 4mm (BA)
10cc (2102-1500)
25 x 100 x 8mm
20cc (2102-1120)
25 x 100 x 8mm (BA)
20cc (2102-1520)
25 x 240 x 4mm
24cc (2102-1101)
25 x 50 x 4mm
5cc (2102-1105)
25 x 50 x 4mm (BA)
5cc (2102-1505)
90% incorporation of graft with BMA was achieved during impaction grafting
versus 40% for controls (historical).
The addition of autologous marrow is a cheap and highly effective way of
achieving graft incorporation.28
25 x 50 x 8mm
10cc (2102-1110)
25 x 50 x 8mm (BA)
10cc (2102-1510)
75 x 100 x 4mm
30cc (2102-1130)
10cc
(2105-0010)
20cc
(2105-0020)
30cc
(2105-0030)
Canisters
Vitoss Canisters offer the handling and delivery
of Vitoss Morsels with the use of bone marrow
aspirate or blood. It is a closed system designed to minimize handling and exposure to potential contaminants.
5cc Micro
(2102-0026)
5cc Standard
(2102-0030)
Foam Strip*
Syringes
10cc Micro
(2102-0027)
10cc Standard
(2102-0031)
15cc Micro
(2102-0028)
Needles
11 gauge x 4 inch
(2090-0027)
11 gauge x 6 inch
(2090-0028)
8 gauge x 6 inch
(2090-0029)
8 gauge x 8 inch
(2090-0047)
Fenestrated
8 gauge x 6 inch
(2090-0030)
15cc Standard
(2102-0032)
30cc Micro
(2102-0029)
30cc Standard
(2102-0033)
Bullet-tip
Sharp-tip
Cups
Foam Flow
5cc
(2102-1305)
10cc
(2102-1310)
3 Weeks
6 Weeks
12 Weeks
52 Weeks
VITOSSTM
Morsels
Foam Pack*
Imbibe
1.2cc
sponge
15cc Macro
(2102-0020)
golf ball
other
scaffolds
porosity
ActiFuse
2.5cc
5cc
30cc Macro
(2102-0021)
(2102-1405)
(2102-1605) BA
(2102-2105) BA
10cc
(2102-1410)
(2102-1610) BA
(2102-2110) BA
ProOsteon
structure
(2102-1401)
(2102-1601) BA
(2102-2101) BA2X
(2102-1402)
(2102-1602) BA
(2102-2102) BA
VITOSS
1.2cc Blocks
(2102-0013)
10cc Blocks
(2102-0006)
MasterGraft
bioactivity11
Bioactive glass has shown positive bondingto-bone properties.12-14 Upon implantation, the
ionic constituents (Si+, Na+, Ca2+) of bioactive
glass are released into the surrounding environment and react with the bodily fluids.18-21 This
reaction produces the deposition of a thin layer
of physiologic CaP at its surface, thus attracting
osteoblasts to the layer to create a matrix that
promotes an osteostimulatory effect.12-18 This may
lead to the bonding of new bone to the scaffold.
Comparison of VITOSS to ActiFuse, ProOsteon, and MasterGraft in a canine metaphyseal study in order to radiologically compare
healing at 3, 6, 12, 24, and 52 weeks. A 10mm x 22mm drill defect was created in the proximal humerus and lled with 2cc of bone graft.24
25
chemistry
There are over 175 references supporting the use of bone marrow for grafting.25
Less/no morbidity
25 x 100 x 4mm
10cc (2102-1100)
25 x 100 x 4mm (BA)
10cc (2102-1500)
25 x 100 x 8mm
20cc (2102-1120)
25 x 100 x 8mm (BA)
20cc (2102-1520)
25 x 240 x 4mm
24cc (2102-1101)
25 x 50 x 4mm
5cc (2102-1105)
25 x 50 x 4mm (BA)
5cc (2102-1505)
90% incorporation of graft with BMA was achieved during impaction grafting
versus 40% for controls (historical).
The addition of autologous marrow is a cheap and highly effective way of
achieving graft incorporation.28
25 x 50 x 8mm
10cc (2102-1110)
25 x 50 x 8mm (BA)
10cc (2102-1510)
75 x 100 x 4mm
30cc (2102-1130)
10cc
(2105-0010)
20cc
(2105-0020)
30cc
(2105-0030)
Canisters
Vitoss Canisters offer the handling and delivery
of Vitoss Morsels with the use of bone marrow
aspirate or blood. It is a closed system designed to minimize handling and exposure to potential contaminants.
5cc Micro
(2102-0026)
5cc Standard
(2102-0030)
Foam Strip*
Syringes
10cc Micro
(2102-0027)
10cc Standard
(2102-0031)
15cc Micro
(2102-0028)
Needles
11 gauge x 4 inch
(2090-0027)
11 gauge x 6 inch
(2090-0028)
8 gauge x 6 inch
(2090-0029)
8 gauge x 8 inch
(2090-0047)
Fenestrated
8 gauge x 6 inch
(2090-0030)
15cc Standard
(2102-0032)
30cc Micro
(2102-0029)
30cc Standard
(2102-0033)
Bullet-tip
Sharp-tip
Cups
Foam Flow
5cc
(2102-1305)
10cc
(2102-1310)
3 Weeks
6 Weeks
12 Weeks
52 Weeks
VITOSSTM
Morsels
Foam Pack*
Imbibe
1.2cc
sponge
15cc Macro
(2102-0020)
golf ball
other
scaffolds
porosity
ActiFuse
2.5cc
5cc
30cc Macro
(2102-0021)
(2102-1405)
(2102-1605) BA
(2102-2105) BA
10cc
(2102-1410)
(2102-1610) BA
(2102-2110) BA
ProOsteon
structure
(2102-1401)
(2102-1601) BA
(2102-2101) BA2X
(2102-1402)
(2102-1602) BA
(2102-2102) BA
VITOSS
1.2cc Blocks
(2102-0013)
10cc Blocks
(2102-0006)
MasterGraft
bioactivity11
Bioactive glass has shown positive bondingto-bone properties.12-14 Upon implantation, the
ionic constituents (Si+, Na+, Ca2+) of bioactive
glass are released into the surrounding environment and react with the bodily fluids.18-21 This
reaction produces the deposition of a thin layer
of physiologic CaP at its surface, thus attracting
osteoblasts to the layer to create a matrix that
promotes an osteostimulatory effect.12-18 This may
lead to the bonding of new bone to the scaffold.
Comparison of VITOSS to ActiFuse, ProOsteon, and MasterGraft in a canine metaphyseal study in order to radiologically compare
healing at 3, 6, 12, 24, and 52 weeks. A 10mm x 22mm drill defect was created in the proximal humerus and lled with 2cc of bone graft.24
25
chemistry
There are over 175 references supporting the use of bone marrow for grafting.25
Less/no morbidity
25 x 100 x 4mm
10cc (2102-1100)
25 x 100 x 4mm (BA)
10cc (2102-1500)
25 x 100 x 8mm
20cc (2102-1120)
25 x 100 x 8mm (BA)
20cc (2102-1520)
25 x 240 x 4mm
24cc (2102-1101)
25 x 50 x 4mm
5cc (2102-1105)
25 x 50 x 4mm (BA)
5cc (2102-1505)
90% incorporation of graft with BMA was achieved during impaction grafting
versus 40% for controls (historical).
The addition of autologous marrow is a cheap and highly effective way of
achieving graft incorporation.28
25 x 50 x 8mm
10cc (2102-1110)
25 x 50 x 8mm (BA)
10cc (2102-1510)
75 x 100 x 4mm
30cc (2102-1130)
10cc
(2105-0010)
20cc
(2105-0020)
30cc
(2105-0030)
Canisters
Vitoss Canisters offer the handling and delivery
of Vitoss Morsels with the use of bone marrow
aspirate or blood. It is a closed system designed to minimize handling and exposure to potential contaminants.
5cc Micro
(2102-0026)
5cc Standard
(2102-0030)
Foam Strip*
Syringes
10cc Micro
(2102-0027)
10cc Standard
(2102-0031)
15cc Micro
(2102-0028)
Needles
11 gauge x 4 inch
(2090-0027)
11 gauge x 6 inch
(2090-0028)
8 gauge x 6 inch
(2090-0029)
8 gauge x 8 inch
(2090-0047)
Fenestrated
8 gauge x 6 inch
(2090-0030)
15cc Standard
(2102-0032)
30cc Micro
(2102-0029)
30cc Standard
(2102-0033)
Bullet-tip
Sharp-tip
Cups
Foam Flow
5cc
(2102-1305)
10cc
(2102-1310)
200
180
160
140
120
100
80
60
40
20
0
Craniomaxillofacial
What makes Iliac Crest Bone Graft (ICBG) the gold standard?
Spine
Scaffold
Orthobiologics
Surgical Products
20
07
20
06
20
05
20
04
20
03
20
02
20
01
20
00
19
99
19
98
19
96
The #1 Synthetic
Bone Graft1
Interventional Spine
Year
Navigation
Currently, there are over 180 510(k) clearances for orthopaedic bone graft
products. Because of the vast number of products available, it is often
difficult for surgeons to assess the best choices for bone grafting.5
Epstein, N.E., An analysis of Noninstrumented Posterolateral Lunbar Fusions Performed
in Predominantly Geriatric Patients Using Lamina Autograft and Beta-Tricalcium Phosphate. The Spine Journal, February 2008.
Study Design:
Prospective; 60 patients using Noninstrumented PLF; Average age = 70 years
Outcome Measures:
CT scans - Fusion assessment; Dynamic X-rays; Fusion assessed separately by 2 neuroradiologists blinded to the treatment; Post-operative outcomes using SF-36; 3, 6, 12, and
24 months follow up
Results:
Successful fusion in 85% of patients (51/60) when judged by CT and F/E
Epstein, N.E., Beta-Tricalcium Phosphate: Observation of Use in 100 Posterolateral
Lumbar Instrumented Fusions. The Spine Journal, June 2009.
Study Design:
Prospective; 100 patients with lumbar spinal stenosis; Multisegment laminectomies (avg. 3.6
segments) and one segment (78 patients) or two segment (22 patients) instrumented PLF
Outcome Measures:
Dynamic X-rays; 2D-CT Scans; Post-operative outcomes using SF-36; Fusion assessed
separately by 2 neuroradiologists blinded to the treatment; 3, 4.5, 6, and 12 month follow
up with a minimum of 2.5 years and maximum of 5.0 years (avg. 3.1 years)
Results:
Successful fusion in 95% of patients (95/100) when judged by CT and Dynamic X-ray
The vast majority of products have no human clinical data to support their use.
Ultimately, human clinical data should be used to select a bone graft.
5
Endoscopy
1 - Millennium Research Group: US Markets for Orthopedic Biomaterials 2010.
2 - Peter Ullrich Jr., Autograft: The Patient's Own Bone. Published in 9/8/99 and updated on 11/25/09 on Spine Universe.
3 - Bellincampi, L., Clineff, T., Erbe, E., Osteoinductivity of Vitoss with Isologous Bone Marrow in Urist Rat Pouch Model.
Society for Biomaterials, Tampa, FL, April 24-27, 2002 (Podium).
4 - www.fda.gov, MQV products, November 2007.
5 - The Evolving Role of Bone Graft Substitutes. American Academy of Orthopaedic Surgeons 77th Annual Meeting,
March 9-13, 2010.
6 - Stryker Orthobiologics Internal Sales Data, July 2011.
7 - Vitoss Bibliography, P/N 5606-0117 Rev. 00, 2010.
8 - Motomiya, M., et al., Effect of Hydroxyapatite Porous Characteristics on Healing Outcomes in Rabbit Posterolateral
Spinal Fusion Model. European Spine Journal, 2007; 16: 2215-2224.
9 - Orthovita Test Report P/N 1070-0008R.
10 - Orthovita Test Report P/N 1050-0003R.
11 - Characteristics of Vitoss BA Product.
12 - Hench, L.L., Splinter, R.J., and Allen, W.C., Bonding Mechanisms at the Interface of Ceramic Prosthetic Materials.
Journal of Biomedical Materials Research, 1971; 2(1): 117-141.
13 - Hench, L.L., Paschall, H.A., Direct Chemical Bond of Bioactive Glass-Ceramic Materials to Bone and Muscle.
Journal of Biomedical Materials Research, 1973; 4: 25-42.
14 - Gross, U., The Interface of Various Glasses and Glass Ceramics with a Bony Implantation Bed. Journal of Biomedical
Materials Research, 1985; 19: 251-271.
15 - Sanders, D.M., Hench, L.L., Mechanisms of Glass Corrosion. Journal of American Ceramic Society. 1973; 56(7): 373-377.
16 - Hench, L.L., Characterization of Glass Corrosion and Durability. Journal of Non-Crystalline Solids, 1975; 19: 27-39.
17 - Ogino, M., Hench, L.L., Formation of Calcium Phosphate Films on Silicate Glasses. Journal of Non-Crystalline Solids,
1980; 38 and 39: 673-678.
18 - Vrouwenvelder, W.C.A., Histological and Biochemical Evaluation of Osteoblasts Cultured on Bioactive Glass,
Hydroxyapatite, Titanium Alloy, and Stainless Steel. Journal of Biomedical Materials Research, 1993 Apr; 27(4): 465-75.
19 - Hench, L.L., The Story of Bioglass. Journal of Materials Science: Materials in Medicine, 2006 Nov; 17(11): 967-78.
20 - Oonishi, H., et al., Particulate Bioglass Compared with Hydroxyapatite as a Bone Graft Substitute. Clinical Orthopaedics
and Related Research, 1997 Jan; 334: 316-25.
21 - Xynos, I.D., Edgar, A.J., Buttery, L.D.K., Hench, L.L., and Polak, J.M., Ionic Products of Bioactive Glass Dissolution Increase
Proliferation of Human Osteoblasts and Induce Insulin-like Growth Factor II mRNA Expression and Protein Synthesis.
Biochemical and Biophysical Research Communications, 2000 September 24; 276(2): 461-5.
22 - Anker et al, Ultraporous Beta-Tricalcium Phosphate is Well Incorporated in Small Cavitary Defects. Clinical
Orthopaedics and Related Research, 2005 May; 434: 251-7.
23 - Brown, LS, Darmoc, MM, Owsiany, RS, Clineff, TD, Improvements in Healing with a Bioactive Bone Graft
Substitute in a Canine Metaphyseal Defect. 55th Annual Meeting of the Orthopaedic Research Society, 2009.
24 - Havener, MB, Clineff, TD, Darmoc, MM, Brown, LS, Owsiany, R, A Comparative Study of Synthetic Bone Graft
Substitutes in a Canine Metaphyseal Defect. 54th Annual Meeting of the Orthopaedic Research Society, 2008.
25 - Marx, J., Bone Marrow: A Validated Biological Driver for Bone Regeneration, White Paper.
26 - Muschler, G.F., Nakamoto, C., Griffith, L.G., Engineering Principles of Clinical Cell-Based Tissue Engineering.
Journal of Bone and Joint Surgery, 2004; 86(7): 1541.
27 - Curylo, L.J., et al., Augmentation of Spinal Arthrodesis With Autologous Bone Marrow in a Rabbit Posterolateral Spine
Fusion Model. Spine, 1999 March 1, 24(5 ): 434-8.
28 - Deakin, D.E., Bannister, G.C., Graft Incorporation After Acetabular and Femoral Impaction Grafting With Washed
Irradiated Allograft and Autologous Marrow. The Journal of Arthroplasty, 2007 January; 22(1): 89-94.
29 - Kim, K.J., et al., Effect of Bone Marrow Grafting on the Titanium Porous-Coated Implant in Bilateral Total Knee
Arthroplasty. Acta Orthopaedica, 2007 February; 78(1): 116-22.
Communications
Imaging
Signal
EMS Equipment
Cells
Scaffold
Autograft (ICBG)
A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular
product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be
trained in the use of any particular product before using it in surgery. The information presented in this brochure is
intended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructions
before using any Stryker product. Products may not be available in all markets. Product availability is subject to the
regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have
questions about the availability of Stryker products in your area.
Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks
or service marks: Imbibe, Stryker, Vitoss. All other trademarks are trademarks of their respective owners or holders.
Literature Number: 5701-0000 Rev. 00
AQ/LW 08/11
Copyright 2011 Stryker
Printed in USA
Vertebral Body
(via pedicle)
Iliac Crest (PSIS, ASIS)
Calcaneus