NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM— 510(k) K955778

Clearance details

Applicant

Intermedics Orthopedics

Product code

Code HRY

Device class

Class 2

Regulation

21 CFR 888.3530

Advisory panel

Orthopedic

Date received

1995-12-20

Decision date

1996-03-08

Decision

Substantially Equivalent for Some Indications

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

• K970300 — NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI1997-07-03
• K970498 — NATURAL-KNEE II REVISION FEMORAL SPACER LUGS1997-04-30
• K970166 — NATURAL-HIP SYSTEM COCR REVISION STEM1997-04-08
• K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS1997-02-27
• K964357 — NATURAL-HIP SYSTEM COCR STEM1997-01-27

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-1251-2014 — Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CONG TIB INS SZ3/4 9MM UN CONG TIB INS SZ3/4 11MM U CONG TIB INS SZ3/4 13MM U CONG TIB INS SZ 5/6 9MM U CONG TIB INS SZ5/6 11MM U CONG TIB INS SZ5/6 13MM UClass II·Terminated·Zimmer, Inc.·20140225

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955778.