SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS— 510(k) K051977

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K051977 for SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS, Substantially Equivalent on 2005-10-12. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2005-07-21
Decision date: 2005-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
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.