M2A 32MM TAPER SYSTEM— 510(k) K003363

Name: FDA 510(k) clearance K003363
Creator: U.S. Food and Drug Administration
Published: 2000-12-15

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K003363 for M2A 32MM TAPER SYSTEM, Substantially Equivalent on 2000-12-15. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code KWY
Device class: Class 2
Regulation: 21 CFR 888.3390
Advisory panel: Orthopedic
Date received: 2000-10-27
Decision date: 2000-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWY

view all

K253357 — b-ONE® Bipolar Head2026-04-13
K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip)2025-08-25
K231526 — CORAIL Cemented Femoral Stem2023-12-19
K223441 — SpaceFlex Acetabular Cup2023-03-23
K221794 — Vario-Cup System2022-07-20

More clearances from Biomet, Inc.

view all

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

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.