EMPOWR Revision Symmetric Knee Cones— 510(k) K240324

Name: FDA 510(k) clearance K240324
Creator: U.S. Food and Drug Administration
Published: 2024-04-26

Substantially Equivalent

Encore Medical, L.P. (Dba Enovis)

FDA 510(k) clearance K240324 for EMPOWR Revision Symmetric Knee Cones, Substantially Equivalent on 2024-04-26. Applicant: Encore Medical, L.P. (Dba Enovis). Device class: 2.

Clearance details

Applicant: Encore Medical, L.P. (Dba Enovis)
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2024-02-02
Decision date: 2024-04-26
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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K261563 — Freedom Total Knee System (E-Poly Tibial Liners)2026-08-07
K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)2026-07-31
K261734 — Klassic Infection Spacer System2026-07-23
K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System2026-06-25
K261032 — NovoKnee (SteriKnee)2026-04-27

More clearances from Encore Medical, L.P. (Dba Enovis)

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K230169 — EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert2023-04-06
K230441 — EMPOWR Stem Extender, 50mm2023-03-17

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.