OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS— 510(k) K884398

Substantially Equivalent for Some Indications

Osteonics Corp.

FDA 510(k) clearance K884398 for OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS, Substantially Equivalent for Some Indications on 1989-01-17. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 1988-10-19
Decision date: 1989-01-17
Decision: Substantially Equivalent for Some Indications
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.