EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones)— 510(k) K251241

Name: FDA 510(k) clearance K251241
Creator: U.S. Food and Drug Administration
Published: 2025-07-02

Substantially Equivalent

Encore Medical L.P.

FDA 510(k) clearance K251241 for EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones), Substantially Equivalent on 2025-07-02. Applicant: Encore Medical L.P.. Device class: 2.

Clearance details

Applicant: Encore Medical L.P.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2025-04-22
Decision date: 2025-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

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K260063 — GSPE Spacer2026-09-11
K262293 — EVOLUTION MPX Total Knee System2026-09-10
K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
K262130 — ATTUNE Revision Knee System2026-09-04
K253961 — SK Knee System2026-09-01

More clearances from Encore Medical L.P.

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K252567 — AltiVate Reverse® ADLC Glenosphere2026-01-15
K252974 — EMPOWR Knee2025-12-19
K251833 — EMPOWR Acetabular® Liner Extension2025-11-12
K252141 — AltiVate Reverse® Glenoid2025-08-05
K251776 — EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)2025-07-08

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.