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X3 Advanced Bearing Technology

Reducing Wear

Knee Simulator wear testing was conducted to determine the difference in wear between the Triathlon CR and PS Knee Systems with X3 Advanced Bearing Technology versus standard gamma sterilized/inert environment UHMWPE.

The Triathlon CR and PS Knee System wear rates are 64.0% to 68.0% lower with X3 Advanced Bearing Technology versus standard gamma sterilized/inert environment UHMWPE.1-4

Triathlon PS Knee wear rates with X3 Advanced Bearing Technology are 96% lower than the leading competitive premium bearing technology.5

Implant wear is one of the non-patient related causes of implant failure. By helping to reduce wear, these implants have a potential to last longer.

Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademark(s) or service mark(s): Triathlon, Polyethylene X3. All other trademarks are trademarks of their respective owners or holders.
References

1. Stryker Orthopaedics Test Report: RD-04-110.

2. Stryker Orthopaedics Test Report: RD-05-010.

3. Stryker Orthopaedics Triathlon CR Tibial Inserts made from X3 UHMWPE, 5530-G-409 show a 68% reduction in volumetric wear rate versus the same insert fabricated from N2\Vac gamma sterilized UHMWPE, 5530-P-409. The insert tested was Size 4, 9 mm thick. Testing was conducted under multiaxial knee simulator (multi-station MTS knee joint simulator a) for five million cycles using appropriate size CoCr counterfaces, a specific type of diluted calf serum lubricant and the motion and loading conditions, representing normal walking, outlined in ISO/DIS 14243-3. Volumetric wear rates were 17.7 ± 2.2 mm 3 /10 6 cycles for standard polyethylene inserts and 5.7 ± 1.5 mm 3 /10 6 cycles for test samples. Test inserts were exposed to a gas plasma sterilization process. In vitro knee wear simulator tests have not been shown to quantitatively predict clinical wear performance.

4. Stryker Orthopaedics Triathlon PS Tibial Inserts made of X3 UHMWPE, 5532-G-409 show a 64% reduction in volumetric wear rate versus the same insert fabricated from N2\Vac gamma sterilized UHMWPE, 5532-P-409. The insert tested was Size 4, 9 mm thick. Testing was conducted under multiaxial knee simulator (multi-station MTS knee joint simulator a) for five million cycles using a size 7 CoCr counterfaces, a specific type of diluted calf serum lubricant and literature or fluoroscopy based motion and loading conditions representing stair climbing. b,c Volumetric wear rates were 3.6 ± 0.61 mm 3 /10 6 cycles for standard polyethylene inserts and were 1.3 ± 0.44 mm 3 /10 6 cycles for test samples. Test inserts were exposed to a gas plasma sterilization process. In vitro knee wear simulator tests have not been shown to quantitatively predict clinical wear performance.

5. X3 UHMWPE maintains mechanical properties after accelerated oxidative aging. No statistical difference was found for Tensile Yield Strength, Ultimate Tensile Strength and Elongation as measured per ASTM D638 before and after exposure to ASTM F2003 accelerated aging (5 Atmospheres (ATM) of oxygen at 70ºC for 14 days). Tensile Yield Strength was 23.5 +/- 0.3 MPa and 23.6 +/- 0.2 MPa, Ultimate Tensile Strength was 56.7 +/- 2.1 MPa and 56.3 +/- 2.3 MPa and Elongation was 267 +/- 7% and 266 +/- 9% before and after accelerated oxidative aging, respectively.