Active-V Total Knee System; World Total Knee System

The Active-V and World Total Knee Systems are modular total knee replacement prostheses intended for patients with degenerative joint disease, rheumatoid arthritis, functional deformity, or failed prior treatments. The devices consist of femoral and tibial components, meniscal inserts, patella, and tibial augments, available in cemented or cementless fixation with various constraint options (CR, PS, UC, MC, CCK variants).

The subject devices use the same materials (cobalt chrome for femoral, Ti6Al4V for tibial, UHMWPE for inserts), fixation methods, operating principles, sizes, and basic design as predicates. Minor differences include new porous coating specifications (plasma-sprayed commercially pure titanium and hydroxyapatite with optional titanium nitride), additional constraint options (CCK and MC variants), and tibial augment components.

Testing followed FDA Guidance on 'Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-coated Uncemented Prostheses.' Specific engineering evaluations included Finite Element Analysis (FEA) on the tibial baseplate and Range of Motion (ROM) analysis on constrained insert variants.

Both subject devices have identical intended use and indications for use as their predicate devices. They employ the same operating principle, basic design, and manufacturing materials. Minor differences do not raise different safety or effectiveness concerns as demonstrated by performance testing. The devices are at least as safe and effective as the legally marketed predicates.