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When a mechanical alignment approach is utilized, these devices are indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis;
• avascular necrosis of the femoral condyle;
• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• moderate valgus, varus or flexion deformities;
• treatment of fractures that are unmanageable using other techniques.

These devices may also be indicated in the salvage of previously failed surgical attempts.

When the EMPOWR® Dynamic Natural Alignment (DNA) approach is utilized, these devices are indicated for patients with disability due to:

• degenerative, post-traumatic or rheumatoid arthritis;
• avascular necrosis of the femoral condyle;
• moderate valgus, varus or flexion deformities.

All EMPOWR devices except for the EMPOWR Revision Knee™, EMPOWR PS Knee™, and EMPOWR Partial Knee™ may be implanted using the EMPOWR® Dynamic Natural Alignment (DNA) surgical technique.

All devices are intended for cemented applications except for the EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia, and Porous Patella which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

Enovis™ knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The purpose of this submission is to obtain clearance for the EMPOWR® Dynamic Natural Alignment (DNA) surgical technique. The proposed technique is a kinematic alignment (KA) strategy, providing an alternative alignment approach to the current mechanical alignment (MA) strategy. The purpose of the KA technique is to restore normal knee function by preserving the patient's native joint line. The technique may be used to implant all EMPOWR devices except for the EMPOWR Revision Knee™ and the EMPOWR PS Knee™. This is a labeling change only. No design changes are being introduced to the implant systems.

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