UNI KNEE— 510(k) K022437

Clearance details

Applicant

Encore Medical L.P.

Product code

Code HRY

Device class

Class 2

Regulation

21 CFR 888.3530

Advisory panel

Orthopedic

Date received

2002-07-25

Decision date

2002-08-23

Decision

Substantially Equivalent

Clearance type

Special

Location

Austin, TX, US

• K193549 — SIGMA High Performance (HP) Partial Knee System2020-04-16
• K190633 — NanoOrtho NanoKnee® System2019-12-20
• K152631 — MPO Total Knee Systems MR Labeling2016-03-23
• K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM2015-03-20
• K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)2014-03-28

• 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

Injury

1,551

Malfunction

2,753

Total

4,304

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 →