AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN— 510(k) K033489

Name: FDA 510(k) clearance K033489
Creator: U.S. Food and Drug Administration
Published: 2004-06-02

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K033489 for AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN, Substantially Equivalent on 2004-06-02. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code MBH
Device class: Class 2
Regulation: 21 CFR 888.3565
Advisory panel: Orthopedic
Date received: 2003-11-04
Decision date: 2004-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

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.