OMKNEE SYSTEM— 510(k) K854883

Substantially Equivalent

Orthomet, Inc.

FDA 510(k) clearance K854883 for OMKNEE SYSTEM, Substantially Equivalent on 1986-02-18. Applicant: Orthomet, Inc..

Clearance details

Applicant: Orthomet, Inc.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 1985-12-06
Decision date: 1986-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, 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.