Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique

The Evolution® Total Knee Systems Kinematic Alignment Instrumentation and Technique is a surgical instrument set designed to guide knee replacement procedures using a kinematic alignment approach. The instruments include resection guides, alignment guides, shims, gauges, calipers, spacers, and trays used with existing Evolution® knee implant components. It is indicated for noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), and correction of functional deformity.

The subject devices possess similar technological characteristics, overall design, materials of construction, principles of operation, and fundamental scientific technology as the predicate devices. The kinematic alignment technique prioritizes femoral cuts to replicate the native joint line and compensate for femoral wear to achieve natural ligament tension, unlike mechanical alignment which emphasizes perpendicular tibial resection.

Not stated in this summary.

The subject and predicate devices share identical intended use and indications. Nonclinical testing including range of motion, tibiofemoral stability, and patellofemoral stability on predicate devices supports substantial equivalence. The kinematic alignment instruments underwent cadaveric validation demonstrating the surgical technique and instrumentation are as safe and effective as predicate devices. The compatible implants are unchanged from previously cleared Evolution® components, and risks identified with the new surgical technique were mitigated by technical rationales in comparison to predicate testing on resection angles, force analysis, and wear.