Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert

The Triathlon® X3® Medial Stabilized Tibial Bearing Insert is a sterile, single-use tibial bearing component for primary or revision total knee replacement surgery. It features an asymmetric articulating surface designed to increase medial conformity with compatible femoral components, providing increased sagittal stability and more natural rotational kinematics. The device includes a titanium alloy (Ti-6Al-4V) locking wire for assembly with the tibial baseplate.

The key technological characteristics include an asymmetric articulating surface geometry (versus symmetric designs in predicates), material characterization of ultra-high-molecular-weight polyethylene (UHMWPE), a titanium alloy locking wire subcomponent, and contact area/stress analysis demonstrating increased medial conformity. Non-clinical testing included wear testing, range of motion and constraint analyses, fretting corrosion analysis, MRI safety evaluations, and biocompatibility testing per ISO 10993-1:2020.

ISO 13485 (Design controls, nonconforming product, corrective/preventive action); ISO 11607-1:2019 and ISO 11607-2:2019 (Shelf-life); ASTM F1980-21, ASTM F1886/F1886M-16, ASTM F88/88M-21, ASTM F2096-11(2019) (Sterilization and shelf-life); ASTM F2052-21, ASTM F2213-17, ASTM F2119-24, ASTM F2182-19e2 (MRI safety); ISO 10993-1:2020 (Biocompatibility); ANSI/AAMI ST72:2019 (Bacterial endotoxin testing).