EMPOWR Acetabular® Liner Extension
FDA 510(k) K251833 · Encore Medical L.P.
510(k) numberK251833
Submission
- Device name
- EMPOWR Acetabular® Liner Extension
- Applicant
- Encore Medical L.P.
Austin, TX, US - Received
- June 16, 2025
- Decision date
- November 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LPH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253630 | Mpact 3D Metal FoamLPH · Traditional | Medacta International S.A. | 08/28/2026SE |
| K254043 | TRIVANCE Hip StemLPH · Traditional | Globus Medical, Inc. | 08/04/2026SE |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…LPH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/10/2026SE |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…LPH · Traditional | Nextstep Arthopedix, LLC | 06/05/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | Biomet, Inc. | 05/19/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | Zimmer, Inc. | 02/04/2026SE |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | Medacta International S.A. | 01/28/2026SE |
| K252067 | Velora Acetabular SystemLPH · Traditional | Restor3D, Inc. | 12/05/2025SE |
| K252846 | TaperSet Hip SystemLPH · Special | Shalby Advanced Technologies, Inc. Dba Consensus… | 11/20/2025SE |
| K251718 | ArTT Augments and Buttresses and Bone ScrewsLPH · Traditional | Lima Corporate S.P.A. | 08/29/2025SE |
More from Lima Corporate S.P.A.
| 510(k) | Device | Decision |
|---|---|---|
| K252567 | AltiVate Reverse® ADLC GlenospherePHX · Traditional | 01/15/2026SE |
| K252974 | EMPOWR KneeJWH · Traditional | 12/19/2025SE |
| K252141 | AltiVate Reverse® GlenoidPHX · Special | 08/05/2025SE |
| K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)JWH · Special | 07/08/2025SE |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones)JWH · Traditional | 07/02/2025SE |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…PHX · Special | 05/16/2025SE |
| K241483 | ceramys femoral head systemLZO · Traditional | 02/07/2025SE |
| K233481 | AltiVate Reverse® GlenoidPHX · Traditional | 05/29/2024SE |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated | 06/23/2023SE |
| K213387 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Traditional | 07/07/2022SE |
Questions and answers
When was EMPOWR Acetabular® Liner Extension cleared by the FDA?
EMPOWR Acetabular® Liner Extension (K251833) received a 510(k) decision of Substantially Equivalent on November 12, 2025, 149 days after the submission was received.
What is the product code of K251833?
The FDA product code is LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.