AGC UNICOMPARTMENTAL KNEE PROSTHESIS— 510(k) K873601

Name: FDA 510(k) clearance K873601
Creator: U.S. Food and Drug Administration
Published: 1988-01-20

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K873601 for AGC UNICOMPARTMENTAL KNEE PROSTHESIS, Substantially Equivalent on 1988-01-20. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code HRY
Device class: Class 2
Regulation: 21 CFR 888.3530
Advisory panel: Orthopedic
Date received: 1987-08-24
Decision date: 1988-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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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

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Adverse events under product code HRY

product code HRY

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.