# K191325: EMPOWR Partial Knee

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Jul 16, 2019 after 61 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K880155 (1988). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033363: Zimmer Unicompartmental Knee System, Zimmer, Inc. (2004) Summary page 4.

## Most influential descendants
- K211471: Balanced Knee System Uni (2021), 0 descendants of its own

## Recalls of this device
- Jun 19, 2020 · Class II · Z-0480-2021: There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg d
- Jun 19, 2020 · Class II · Z-0479-2021: There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg d

## Indications for use
The EMPOWR Partial Knee System is indicated for patients with: • Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. • Previous tibial condyle or plateau fractures with loss of anatomy or function. • Varus or valgus deformities. • Revision procedures where other treatments or devices have failed. • These devices are indicated for cemented use only.

Source page: https://510kreport.com/device/K191325
Methodology: https://510kreport.com/methodology