EXULT Knee Replacement System

The EXULT Knee Replacement System is a total knee joint replacement indicated for painful, disabling knee disease from osteoarthritis, rheumatoid arthritis, post-traumatic loss of function, and moderate deformities, as well as correction of failed prior knee procedures. It is a polymer/metal/polymer semi-constrained cemented prosthesis intended for surgical implantation in patients requiring knee arthroplasty.

The subject device is identical to the predicate in material (UHMWPE per ASTM F648/ISO 5834-2), tibial insert/baseplate design (fixed), locking mechanism (full peripheral capture snap fit with anterior hook and posterior foot), size range (36–57 / 57–86 mm AP/ML), and sterilization (EtO gas). The sole modification is the PCL notch design: the subject device has an open PCL notch, whereas the predicate has a closed notch, allowing surgeons to preserve the posterior cruciate ligament during implantation.

ASTM F2083 (contact area/pressure), ASTM F1814 (interlocking test), ISO 14243-2/3 (wear of articulating surfaces), ISO 21536 (range of motion), ASTM F1223 (constraint analysis), and ASTM F2777 (endurance and deformation under high flexion).

The device is substantially equivalent because the PCL notch modification is a minor design change that does not alter the fundamental intended use, material composition, locking mechanism, or biocompatibility of the prosthesis. All non-clinical performance tests demonstrate comparable or equivalent behavior to the predicate. The modification enables a surgical technique option (PCL retention) rather than a change in the device's safety profile or clinical indication, and the device remains used in combination with identical femoral and tibial baseplate components.