# K223779: EMPOWR™ blade stem

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical, LLC
- Decided: Feb 13, 2023 after 59 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991325 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120241: Linear Hip Stem, Size 5, Encore Medical L.P. (2012) Summary page 4.

## Indications for use
The hip joint metal uncemented prosthesis is intended to replace a hip joint. The device is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered. Joint replacement is indicated for patients suffering from disability due to: • noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; • rheumatoid arthritis; • correction of functional deformity; • femoral fracture; and • revision procedures where other treatments or devices have failed. This stem is to be press-fit. This stem is intended for cementless use.

Source page: https://510kreport.com/device/K223779
Methodology: https://510kreport.com/methodology