Balanced Knee System TriMax Porous Femoral Components

The Balanced Knee® System TriMax® Porous Femoral Components are cobalt-chromium-molybdenum (Co-Cr-Mo) femoral implants used in total knee arthroplasty procedures to replace worn, diseased, or damaged knee joint surfaces. They are available in two configurations (Cruciate Retaining and Posterior Stabilized) and are indicated for conditions including osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, and revision procedures where prior treatments have failed.

The devices are manufactured from cast Co-Cr-Mo alloy with a Co-Cr-Mo sintered porous coating on bone-contacting surfaces. They maintain the same articular geometry and materials of construction as the legally marketed TriMax cemented femoral components, with the primary new feature being the addition of the porous coating, which is substantially equivalent to the reference device (Maxx Orthopedics Freedom Porous Femoral Component K150680).

Testing included ASTM F2083 (range of motion and contact area), ASTM F1223 (femorotibial constraint), ASTM F1672 (patellofemoral constraint and contact area), ASTM F3210 (femoral fatigue strength), ISO 14243 (wear testing), ASTM F1854 (porous coating characterization), ASTM F1044 & F1147 (porous coating static shear and tensile), ASTM F1978 (porous coating abrasion), ASTM F1160 (porous coating shear fatigue), ISO 10993-1 (biocompatibility), and ISO 11137 (sterilization validation).

Substantial equivalence is based on identical indications for use, same technological characteristics and articular geometry as predicate devices, identical Co-Cr-Mo material composition and manufacturing methods, and the porous coating being equivalent to a previously cleared reference device. Verification and validation activities demonstrated the device performs as safely and effectively as the legally marketed predicates.