NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM— 510(k) K033810

Clearance details

Applicant

Centerpulse Orthopedics, Inc.

Product code

Code HRY

Device class

Class 2

Regulation

21 CFR 888.3530

Advisory panel

Orthopedic

Date received

2003-12-08

Decision date

2004-03-05

Decision

Substantially Equivalent

Clearance type

Traditional

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

• K033943 — ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED2004-10-18
• K033634 — EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED2004-09-15
• K040947 — DURASUL BIPOLAR2004-08-27
• K033664 — MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM2003-12-17
• K032348 — CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP2003-10-24

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 →

• Z-1252-2014 — Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mmClass II·Terminated·Zimmer, Inc.·20140225

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033810.