FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING— 510(k) K122239

Name: FDA 510(k) clearance K122239
Creator: U.S. Food and Drug Administration
Published: 2013-04-11

Substantially Equivalent

Encore Medical L.P.

FDA 510(k) clearance K122239 for FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING, Substantially Equivalent on 2013-04-11. 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: 2012-07-27
Decision date: 2013-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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K262130 — ATTUNE Revision Knee System2026-09-04
K253961 — SK Knee System2026-09-01

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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.