# K252974: EMPOWR Knee

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Dec 19, 2025 after 93 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 7 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K143242: Rebel 3DKNEE System, Encore Medical L.P. (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K170573: Empowr CR Knee Tibial Insert, Encore Medical L.P. (2017). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K171991: EMPOWR Porous Knee System, Encore Medical L.P. (2017). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K173723: EMPOWR Universal Tibial Baseplate, Encore Medical L.P. (2018). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K210308: EMPOWR Porous Femur with HAnano SurfaceTM, Encore Medical L.P. (2021). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K121835: Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VE, Encore Medical L.P. (2012). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K212941: Porous Patella, Encore Medical, L.P. Dba Djo Surgical (2022). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
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 TM, EMPOWR PS Knee TM, and EMPOWR Partial Knee TM 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.

Source page: https://510kreport.com/device/K252974
Methodology: https://510kreport.com/methodology