# K251833: EMPOWR Acetabular® Liner Extension

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Nov 12, 2025 after 149 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: 13 generations back to K810258 (1981). 168 ancestors in all.
No later device cites it as a predicate yet.
0 of 169 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190057: DJO Acetabular System, Encore Medical L.P. (2019) Summary page 5.
- K172651: FMP Extended Liners, Encore Medical L.P. (2017) Summary page 5.
- K191622: Delta Multihole TT Pro Acetabular System, Lima Corporate S.P.A. (2019) Summary page 5.
- K241483: ceramys™ femoral head system, Encore Medical L.P. (2025) Summary page 5.
- K062419: Trident Large Diameter Acetabular Inserts, Howmedica Osteonics Corp. (2006) Summary page 5.

## Indications for use
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. This device may also be indicated in the salvage of previously failed surgical attempts. The EMPOWR Dual Mobility™ system has the additional indication of joint replacement due to dislocation risks. The constrained acetabular component is indicated 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 intra-operative instability and for who all other options to constrained acetabular components have been considered.

Source page: https://510kreport.com/device/K251833
Methodology: https://510kreport.com/methodology