INTEGRAL CO-CR FEMORAL COMPONENT— 510(k) K942479

Clearance details

Applicant

Biomet, Inc.

Product code

Code JDG

Device class

Class 2

Regulation

21 CFR 888.3360

Advisory panel

Orthopedic

Date received

1994-05-25

Decision date

1994-09-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve2022-02-07
• K193546 — Distal Centralizers2020-09-25
• K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads2018-03-19
• K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT2000-09-27
• K992234 — THE TAPER-FIT TOTAL HIP SYSTEM1999-11-10

• K253434 — OSSTM Orthopedic Salvage System2026-07-01
• K251270 — Taperloc® Complete Hip Stem2026-05-19
• K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
• K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
• K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

Injury

804

Malfunction

3,242

Total

4,046

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-0650-2016 — Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mmClass II·Terminated·Biomet, Inc.·20151117

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K942479.