P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS— 510(k) K923807

Substantially Equivalent

Johnson & Johnson International

FDA 510(k) clearance K923807 for P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS, Substantially Equivalent on 1992-11-09. Applicant: Johnson & Johnson International.

Clearance details

Applicant: Johnson & Johnson International
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 1992-07-29
Decision date: 1992-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, 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.