EMPOWR Knee

The EMPOWR Knee is a total knee prosthesis (implant) used to treat patients with knee joint disease or damage from arthritis, avascular necrosis, or trauma. It restores mobility and reduces pain in patients with degenerative, post-traumatic, or rheumatoid arthritis, and can be implanted using either a traditional mechanical alignment approach or a new kinematic alignment (DNA) surgical technique.

No design changes to the implant components themselves are being introduced. The device uses the same materials, design features, packaging, and sterilization as existing EMPOWR devices. The only change is the addition of a kinematic alignment surgical technique option for implanting the existing devices, which does not affect the physical implant system.

Not stated in this summary.

Substantial equivalence is based on the fact that no design changes are being made to the implant system itself. Performance testing, including initial stability (micromotion) testing and cadaveric assessment of the kinematic surgical technique, demonstrates that devices implanted using the EMPOWR DNA surgical technique are substantially equivalent to predicate devices. The new technique is merely an alternative surgical approach for implanting existing devices.