EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse

The Evolution and Advance Knee Systems are modular orthopedic implants designed for total knee arthroplasty, revision surgery, and limb salvage procedures. These systems include hinge knee designs, modular distal femoral components, and customizable tibial inserts to address complex joint pathologies, such as severe osteoarthritis, post-traumatic deformities, or oncologic reconstructions. The Repiphysis and Guardian systems specifically target limb salvage applications, providing structural support and stability for patients requiring extensive bone resection or tumor removal. Inserts such as the Adaptive CS, PS, and Ultra-Congruent variants are engineered to optimize joint congruency and load distribution, enhancing long-term durability and patient mobility.

These devices are intended for use in orthopedic operating rooms by trained surgeons and are supplied sterile for single-use. The modular components allow for customization based on patient anatomy and clinical needs, with sizes and configurations detailed in the manufacturer’s technical documentation. The Evolution and Advance systems are classified under FDA 510(k) clearance (K240043) as substantially equivalent to predicate devices, adhering to traditional review pathways. Storage and handling follow standard orthopedic implant protocols to maintain sterility and integrity prior to surgical use.