DURACON PS LIPPED TIBIAL INSERT— 510(k) K012172

Substantially Equivalent

Howmedica Osteonics

FDA 510(k) clearance K012172 for DURACON PS LIPPED TIBIAL INSERT, Substantially Equivalent on 2001-10-10. Applicant: Howmedica Osteonics.

Clearance details

Applicant: Howmedica Osteonics
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2001-07-12
Decision date: 2001-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

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Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.