# K251241: EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Jul 2, 2025 after 71 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K810258 (1981). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240324: EMPOWR Revision Symmetric Knee Cones, Encore Medical, L.P. (Dba Enovis) (2024) Summary page 5.
- K230169: EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert, Encore Medical, L.P Dba Enovis (2023) Summary page 5.

## Indications for use
Total joint replacement is 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. This device may also be indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves cones or extensions. The EMPOWR Revision Knee™ Symmetric TT Cones are indicated for the following conditions: • EMPOWR Revision Knee™ Symmetric TT Cones are indicated for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon. • EMPOWR Revision Knee™ Symmetric TT Cones are indicated for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Source page: https://510kreport.com/device/K251241
Methodology: https://510kreport.com/methodology