Tritanium
In-Growth Technology1
Built to fuse™
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Information for healthcare professionals
Inspired by biology. Enabled by design.
Through precise computer modeling and AMagine manufacturing technology, Tritanium In-Growth Technology is designed to mimic cancellous bone and provide an environment favorable to bone regeneration and fusion.1-5
The Tritanium story
Built with AMagine6
20+ years of leadership in precision manufacturing of complex geometries such as Tritanium In-Growth Technology
Our proprietary AMagine additive manufacturing (AM) process - sometimes called 3D printing or laser rapid manufacturing - has made us a global leader in additive manufactured spinal implants. Here's what it means for you.
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Transforms bright ideas into market realities with potentially increased product development speed•
Helps enable previously difficult or impossible to manufacture implant geometries•
Differentiates porous matrix, shape and other surgical features specifically for each cage’s design•
“Grows” parts layer-by-layer based on stringent computer modeling and incorporates 100+ quality checks per batch•
Designed to provide the high performance, reproducibility and quality you expect1
AMagine the strength6
World's largest AM facility for orthopaedic implants
Trusted worldwide in
750,000+ orthopaedic implants
110,000+ spine implants
110,000+ spine implants
20+ years of AM research
and design expertise
and design expertise
Built to mimic2-4
Tritanium is designed to mimic the porous structure of cancellous bone6-8
Porosity
Cancellous bone
Cancellous bone characteristics
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Avg pore diameter of cancellous bone7 = 600 µm•
Avg porosity of cancellous bone4 = ~50-90%Tritanium In-Growth Technology1
Tritanium material characteristics2,3
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Randomized pore sizing designed to mimic cancellous bone1•
Interconnected pore structure from endplate to endplate3•
Pore size range: 100-700 μm•
Mean pore size range: 400-500 μm•
Mean porosity: 55-65%Porosity and pore size distribution8
•
Cancellous bone has randomized, non-uniform, interconnected porosity comprised of a wide range of pore sizes that serve various biological functions and contribute in concert to the overall biological and mechanical function of the tissue9
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Tritanium is designed to be similar to cancellous bone in total % porosity and pore size distribution9
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Small pores allow for capillary action4,10
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Built to wick
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Medium sized pores allow for cell infiltration11
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Designed to create a favorable environment for cells
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Larger pores allow for bone formation and vascularization4
•
Designed for in-growth
Cancellous Allograft
50-90% porosity8
Tritanium
55-65% porosity8
Built to wick12,13*
Tritanium material may be able to wick or retain fluid in comparison to traditional titanium material12,13
RD 50927 | Tritanium Wicking Evaluation
Tritanium C Cage absorbed 3 times more bone marrow aspirate (BMA) than allograft and 4 times more BMA than PEEK in an in vitro study14
*Tritanium material may be able to wick or retain fluid in comparison to traditional titanium material. This experiment was performed using heparinized porcine bone marrow aspirate. No correlation to human clinical outcomes has been demonstrated or established.
Built to attach and multiply15,16
Bone cells attached, infiltrated, and proliferated within Tritanium's porosity15,16*
A coupon built with Tritanium In-Growth Technology demonstrated that osteoblasts (bone cells) infiltrated, attached to and proliferated throughout the porosity of the Tritanium technology.15,16*
The unique porous structure is designed to create a favorable environment for cell attachment.4,15
* Image depicts a sample built with Tritanium Technology used for in vitro cell studies. The sample was designed to mimic a generic interbody cage with an open graft window. This is not an implantable device.
* No correlation to human clinical outcomes has been demonstrated or established.
Built to differentiate17,18
Stem cells grown on Tritanium exhibited osteogenic Alkaline Phosphatase without requiring growth factor supplements17,18
Tritanium stem cell study17,18
Methodology
•
Evaluated impact of porous architecture and scaffold composition using undifferentiated stem cells
Results
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Expression of Alkaline Phosphatase (ALP) by hMSC grown on a Tritanium coupon increased over time and was 4X greater than that by hMSC on solid Ti by day 1417,18
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Validates Tritanium's randomized porosity
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Influenced the biological response
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Induced osteogenic differentiation without requiring growth factor supplementation
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Peer-reviewed poster presentation at Philadelphia Spine Research Symposium18 - 2019
Tritanium
Solid Titanium
PEEK
What does this mean?
•
Indicates that Tritanium induced undifferentiated stem cells to produce the early osteogenic bone marker, ALP, without requiring growth factors, like BMP-2
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Tritanium architecture is designed to mirror that of cancellous bone in total % porosity and pore size distribution19
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Titanium is known to be bone-friendly20 (ALP activity: Solid Ti > PEEK)
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When titanium is arranged in a configuration that mimics bone (Tritanium vs. solid Ti), osteogenic activity was enhanced
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Supports established literature that PEEK is less conducive to bone formation20
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PEEK showed the lowest ALP activity, followed by Solid Ti, with Tritanium highest
Built for in-growth21*
Bone grew onto and into the porous structure of the Tritanium cage in a preclinical study
Tritanium PL sheep study21,22
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Animal model - ovine lumbar fusion:
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Two level (L2-L3 and L4-L5) lumbar fusion with iliac crest autograft
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Groups:
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Tritanium PL Cage
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PEEK Cage
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Plasma-sprayed Titanium-coated PEEK Cage (PSP)
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Time points:
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8 weeks
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16 weeks
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Analyses:
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Histology
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Biomechanics – Range of Motion / Stiffness
* Correlation to human clinical outcomes has not been demonstrated or established
VIEW STUDY
Histology summary
Bone content - total region of interest (ROI)
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Tritanium: significant increase in bone content over time
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This difference was not evident in PEEK and PSP
Bony bridging - semi-quantitative fusion assessment
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Tritanium:
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Significant increase in bony bridging score over time
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This difference was not evident in PEEK and PSP
•
Significantly greater bony bridging score vs. PEEK and PSP at 16 weeks
Biomechanical summary
Range of motion (ROM) | Tritanium PL Cage:
•
Demonstrated significant decrease in ROM over time in all three loading directions - axial rotation, flexion/extension, and lateral bending
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This difference was not evident in PEEK and PSP
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Significantly lower ROM in flexion/extension vs PEEK at 16 weeks
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Tritanium PL Cage had the lowest ROM mean magnitude in all loading directions at 16 weeks
Inflammation
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Utilizing data from Tri-PL sheep study21, compared inflammatory response for Tri-PL, PEEK, and plasma-sprayed PEEK
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Tri-PL was the only group to show a reduction in inflammation over time23
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By 16 weeks, Tri-PL inflammation was significantly lower than PEEK23
Built to fuse1,5
In a prospective clinical study, Tritanium PL showed higher fusion rates, better patient reported outcomes, lower subsidence, and lower indirect surgical costs versus the propensity-matched PEEK cohort.1,5
Early clinical cases
The Tritanium PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine
Case source: Charles Sansur, MD, FAANS, University of Maryland, Baltimore, MD, USA
Case source: Alan H. Daniels, MD, University of Orthopedics, Providence, RI, USA
Recent peer-reviewed clinical data
Dr. Devin - Clinical study5
In a 228-patient study, 114 patients who underwent elective lumbar interbody fusion surgery for degenerated disc-related diseases received the Tritanium PL implant. These patients were compared against a propensity-matched historic PEEK cohort.
Both the Tritanium and PEEK groups exhibited a significant improvement from baseline measurements in patient reported outcomes at 3- and 12-months. The Tritanium group showed significant improvements in ODI (Oswestry Disability Index) versus PEEK at both 3- and 12-months (p=0.013 at 3 months, p=0.048 at 12 months). At 12-months, radiologic review showed intact fusion of the operative levels in 90% of the Tritanium cohort versus 73% fusion in the PEEK group and a reduced occurrence of subsidence in Tritanium vs. PEEK. While there were no measured differences between groups in return-to-work or direct cost of surgical care, the indirect cost of care was found to be significantly lower for the Tritanium cohort vs. PEEK. (p=0.006)
This study indicates that Tritanium can be an effective alternative to PEEK in the treatment of lumbar degenerative disc diseases.
VIEW STUDY
VIEW STUDY
Material characteristics of
Tritanium In-Growth Technology1
Design characteristic
Tritanium technology
Strong, stiff and biocompatible material24
Highly porous material4,25,26
•
Porosity > 46%
•
Average pore diameter > 300μm
Mean porosity range: 55-65%3
Pore size range: 100-700μm3
Mean pore size range: 400-500μm3
Interconnected porosity27
Porosity on superior and inferior surfaces and within internal walls3
Roughened surface24,28
Coefficient of friction = .9229
Porous architecture reflective of bone composition4
Tritanium material consists of random interconnected architecture with rugged, irregular pore sizes and shapes that are designed to mimic cancellous bone
Manufacturing process capable of reproducible randomization
Utilizes proprietary additive manufacturing technique that is designed to produce completely randomized yet reproducible porous structure
Ability to wick and retain fluid12
Tritanium material may be able to wick or retain fluid in comparison to traditional titanium material.12 Tritanium material demonstrated the ability to wick fluid into the porous structure under specified conditions during an experiment. It also absorbed and held fluid inside the porous structure12
The Tritanium C Cage absorbed 3 times more bone marrow aspirate (BMA) than allograft and 4 times more BMA than PEEK in an in-vitro study14
Realistic environment for cell growth30
Coupon built with Tritanium material demonstrated that osteoblasts (cells) infiltrated, attached to and proliferated on the porosity of the Tritanium technology.15 The unique porous structure is designed to create a favorable environment for cell attachment and proliferation4,15
Note: Tritanium is a novel highly porous titanium material designed for bone in-growth and biological fixation. These claims are exclusively associated with Tritanium Technology, used to build the Tritanium PL, Tritanium C, Tritanium TL and Monterey AL Cages.
Featuring
Tritanium In-Growth Technology1
Built to fuse™
REQUEST MORE INFORMATION
For information or image requests, contact:
Katie Powers
Senior Manager, Marketing Communications
Stryker
Andrea Sampson
President
Sullivan & Associates
1. Stryker data on file; PROJ 43909 Tritanium technology claim support memo
2. Stryker data on file; DHF 53171 Tritanium C
3. Stryker data on file; DHF 42351 Tritanium PL
4. Karageorgiou, V. et al. "Porosity of 3D biomaterial scaffolds and osteogenesis." Biomaterials. 2005, 26:5474–5491.
5. Khan, I. et al. "Clinical and cost-effectiveness of lumbar interbody fusion using Tritanium Posterolateral Cage (vs. propensity-matched cohort of PEEK cage)." Spine Surgery and Related Research, 2022, doi.org/10.22603/ssrr.2021-0252.
6. Stryker data on file; Stryker’s Spine division
7. Holmes RE. J Bone Joint Surg AM (1986) 68: 904-911.
8. Stryker data on file; RD 57968 Tritanium Porosity Quantification via Mercury Porosimetry
9. Loh, Q. et al. "Three-dimensional scaffolds for tissue engineering applications: role of porosity and pore size." Tissue engineering. Part B, Reviews. 2013 Dec;19(6):485-502. doi: 10.1089/ten.TEB.2012.0437. Epub 2013 Jun 25. PMID: 23672709; PMCID:PMC3826579.
10. Oh, D. et al. "Distinctive Capillary Action by Microchannels in Bone-like Templates can Enhance Recruitment of Cells for Restoration of Large Bony Defect." Journal of Visualized Experiments. 2015, 103: 52947. doi:10.3791/52947
11. Boskey, A. et al. "Bone Structure, Composition, and Mineralization." Orthopedic Clinics of North America. 1984, 15: 597-612. doi.org/10.1016/S0030-5898(20)31258-X
12. Stryker data on file; RD 50927 Tritanium material capillary evaluation
13. Stryker data on file; TREP 53045 Tritanium wicking verification test report
14. Stryker data on file; RD 53906 Tritanium Cervical Competitive Wicking Comparison
15. Stryker data on file; RD 53710 Tritanium cell infiltration and attachment experiment
16. Stryker data on file; TREP 53692 Tritanium cell attachment verification – report
17. Stryker data on file; RD 62430 Tritanium hMSC osteogenic differentiation
18. Reza, A. et al. "Randomized porous titanium impacts cell morphology and induces stem cell differentiation in vitro." Orthopaedic Research Society 5th International Spine Research Symposium, 2019, 5: 83.
19. Stryker data on file; RD 57968 Tritanium Porosity Quantification via Mercury Porosimetry
20. Olivares-Navarrete R, Hyzy SL, Slosar PJ, Schneider JM, Schwartz Z, Boyan BD. “Implant materials generate different peri-implant inflammatory factors: poly-ether-ether-ketone promotes fibrosis and microtextured titanium promotes osteogenic factors.” Spine (Phila Pa 1976). 2015 Mar 15;40(6):399-404. doi: 10.1097/BRS.0000000000000778. PMID: 25584952; PMCID: PMC4363266.
21. SRL 15-02/Stryker 02-15 Pre-clinical study final report
22. McGilvray KC, Easley J, Seim HB, Regan D, Berven SH, Hsu WK, Mroz TE, Puttlitz CM. “Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model.” Spine J. 2018 Jul;18(7):1250-1260. doi: 10.1016/j.spinee.2018.02.018. Epub 2018 Feb 26. PMID: 29496624; PMCID: PMC6388616.
23. Stryker data on file; RD 58163 Tritanium PL Sheep Study Inflammation Report
24. Oldani C, Dominguez A. Titanium as a Biomaterial for Implants. Recent Advances in Arthroplasty. Dr. Samo Fokter (Ed.). ISBN: 978-953-307-990-5. 2012. InTech
25. Kujala, S. et al (2003): “Effect of porosity on the osteointegration and bone ingrowth of a weight-bearing nickel–titanium bone graft substitute”, Biomaterials, 24(25), November 2003, Pages 4691-4697
26. Bobyn JD, Pilliar RM, Cameron HU, Weatherly GC. “The optimum pore size for the fixation of porous-surfaced metal implants by the ingrowth of bone.” Clin Orthop Relat Res. 1980 Jul-Aug;(150):263-70. PMID: 7428231.
27. Simon JL, Roy TD, Parsons JR, Rekow ED, Thompson VP, Kemnitzer J, et al. Engineeredcellular response to scaffold architecture in a rabbit trephine defect. J Biomed Mater Res A 2003;66(2):275–82
28. Deligianni, D.D.; Katsala, N.; Ladas, S.; Sotiropoulou, D.; Amedee, J.; & Missirlis, Y.F. (2001) Effect of surface roughness of the titanium alloy Ti-6Al-4V on human bone marrow cell response and on protein adsorption. Biomaterials, 22, 1241-1251
29. Stryker data on file; PROJ 44960 Coefficient of friction memo
30. M. J. Cooke; Enhanced cell attachment using a novel cell culture surface presenting functional domains from extracellular matrix proteins. Cytotechnology. 2008 Feb; 56(2): 71-79
Refer to the Monterey AL, Tritanium PL, Tritanium TL, and Tritanium C surgical techniques and instructions for use for complete product information
This website is intended for physicians only. It is not intended for patients. If you are a patient, you should not rely on the information on this website and should speak to your doctor about whether spinal fusion surgery is right for you.
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 specific products before using them in surgery.
The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in 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: AMagine, Built to fuse,Stryker, Tritanium. All other trademarks are trademarks of their respective owners or holders.
TRITA-WB-2_Rev 3_34241
Copyright © 2022 Stryker
2. Stryker data on file; DHF 53171 Tritanium C
3. Stryker data on file; DHF 42351 Tritanium PL
4. Karageorgiou, V. et al. "Porosity of 3D biomaterial scaffolds and osteogenesis." Biomaterials. 2005, 26:5474–5491.
5. Khan, I. et al. "Clinical and cost-effectiveness of lumbar interbody fusion using Tritanium Posterolateral Cage (vs. propensity-matched cohort of PEEK cage)." Spine Surgery and Related Research, 2022, doi.org/10.22603/ssrr.2021-0252.
6. Stryker data on file; Stryker’s Spine division
7. Holmes RE. J Bone Joint Surg AM (1986) 68: 904-911.
8. Stryker data on file; RD 57968 Tritanium Porosity Quantification via Mercury Porosimetry
9. Loh, Q. et al. "Three-dimensional scaffolds for tissue engineering applications: role of porosity and pore size." Tissue engineering. Part B, Reviews. 2013 Dec;19(6):485-502. doi: 10.1089/ten.TEB.2012.0437. Epub 2013 Jun 25. PMID: 23672709; PMCID:PMC3826579.
10. Oh, D. et al. "Distinctive Capillary Action by Microchannels in Bone-like Templates can Enhance Recruitment of Cells for Restoration of Large Bony Defect." Journal of Visualized Experiments. 2015, 103: 52947. doi:10.3791/52947
11. Boskey, A. et al. "Bone Structure, Composition, and Mineralization." Orthopedic Clinics of North America. 1984, 15: 597-612. doi.org/10.1016/S0030-5898(20)31258-X
12. Stryker data on file; RD 50927 Tritanium material capillary evaluation
13. Stryker data on file; TREP 53045 Tritanium wicking verification test report
14. Stryker data on file; RD 53906 Tritanium Cervical Competitive Wicking Comparison
15. Stryker data on file; RD 53710 Tritanium cell infiltration and attachment experiment
16. Stryker data on file; TREP 53692 Tritanium cell attachment verification – report
17. Stryker data on file; RD 62430 Tritanium hMSC osteogenic differentiation
18. Reza, A. et al. "Randomized porous titanium impacts cell morphology and induces stem cell differentiation in vitro." Orthopaedic Research Society 5th International Spine Research Symposium, 2019, 5: 83.
19. Stryker data on file; RD 57968 Tritanium Porosity Quantification via Mercury Porosimetry
20. Olivares-Navarrete R, Hyzy SL, Slosar PJ, Schneider JM, Schwartz Z, Boyan BD. “Implant materials generate different peri-implant inflammatory factors: poly-ether-ether-ketone promotes fibrosis and microtextured titanium promotes osteogenic factors.” Spine (Phila Pa 1976). 2015 Mar 15;40(6):399-404. doi: 10.1097/BRS.0000000000000778. PMID: 25584952; PMCID: PMC4363266.
21. SRL 15-02/Stryker 02-15 Pre-clinical study final report
22. McGilvray KC, Easley J, Seim HB, Regan D, Berven SH, Hsu WK, Mroz TE, Puttlitz CM. “Bony ingrowth potential of 3D-printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model.” Spine J. 2018 Jul;18(7):1250-1260. doi: 10.1016/j.spinee.2018.02.018. Epub 2018 Feb 26. PMID: 29496624; PMCID: PMC6388616.
23. Stryker data on file; RD 58163 Tritanium PL Sheep Study Inflammation Report
24. Oldani C, Dominguez A. Titanium as a Biomaterial for Implants. Recent Advances in Arthroplasty. Dr. Samo Fokter (Ed.). ISBN: 978-953-307-990-5. 2012. InTech
25. Kujala, S. et al (2003): “Effect of porosity on the osteointegration and bone ingrowth of a weight-bearing nickel–titanium bone graft substitute”, Biomaterials, 24(25), November 2003, Pages 4691-4697
26. Bobyn JD, Pilliar RM, Cameron HU, Weatherly GC. “The optimum pore size for the fixation of porous-surfaced metal implants by the ingrowth of bone.” Clin Orthop Relat Res. 1980 Jul-Aug;(150):263-70. PMID: 7428231.
27. Simon JL, Roy TD, Parsons JR, Rekow ED, Thompson VP, Kemnitzer J, et al. Engineeredcellular response to scaffold architecture in a rabbit trephine defect. J Biomed Mater Res A 2003;66(2):275–82
28. Deligianni, D.D.; Katsala, N.; Ladas, S.; Sotiropoulou, D.; Amedee, J.; & Missirlis, Y.F. (2001) Effect of surface roughness of the titanium alloy Ti-6Al-4V on human bone marrow cell response and on protein adsorption. Biomaterials, 22, 1241-1251
29. Stryker data on file; PROJ 44960 Coefficient of friction memo
30. M. J. Cooke; Enhanced cell attachment using a novel cell culture surface presenting functional domains from extracellular matrix proteins. Cytotechnology. 2008 Feb; 56(2): 71-79
Refer to the Monterey AL, Tritanium PL, Tritanium TL, and Tritanium C surgical techniques and instructions for use for complete product information
This website is intended for physicians only. It is not intended for patients. If you are a patient, you should not rely on the information on this website and should speak to your doctor about whether spinal fusion surgery is right for you.
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 specific products before using them in surgery.
The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in 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: AMagine, Built to fuse,Stryker, Tritanium. All other trademarks are trademarks of their respective owners or holders.
TRITA-WB-2_Rev 3_34241
Copyright © 2022 Stryker