EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)

The EMPOWR Revision Knee is a total knee arthroplasty (TKA) prosthesis system intended for joint replacement in patients with degenerative arthritis, avascular necrosis, post-traumatic joint loss, and deformities. The VVC+, e+ Tibial Insert is specifically designed for patients with absent or damaged cruciate ligaments, moderate instability, or significant bone loss requiring additional constraint and fixation.

The only technological change from the predicate device is the sterilization method: the subject device uses vaporized hydrogen peroxide (VHP) sterilization instead of the predicate's Hydrogen Peroxide Gas Plasma (HPGP) sterilization. All other aspects—materials, design features, indications, and packaging—remain identical to the predicate.

Not stated in this summary.

The device achieves substantial equivalence because the change is limited to sterilization methodology, which does not alter the physical device, materials, design, or indications for use. Verification and validation testing—including sterilization validation, shelf-life studies, packaging testing, cytotoxicity, material characterization, wear, and fatigue testing—demonstrated that VHP sterilization does not compromise device performance or safety compared to HPGP sterilization.