# K203557: EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Feb 10, 2021 after 65 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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: 11 generations back to K810258 (1981). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150522: G7 Dual Mobility System, Biomet, Inc. (2015) Summary page 5.

## Recalls of this device
- Jun 12, 2025 · Class II · Z-2148-2025: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
- Jun 12, 2025 · Class II · Z-2147-2025: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.

## Indications for use
EMPOWR Dual Mobility (Metal Liner and Poly Bearing) is indicated as part of a total hip replacement for patients suffering from pain and dysfunction due to: • Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis • Rheumatoid arthritis • Correction of functional deformity • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques • Revision of previously failed total hip arthroplasty • Dislocation risks • To be used for uncemented applications

Source page: https://510kreport.com/device/K203557
Methodology: https://510kreport.com/methodology