SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT— 510(k) K042883

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K042883 for SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT, Substantially Equivalent on 2004-11-23. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2004-10-19
Decision date: 2004-11-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Mahwah, 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.