Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial— 510(k) K142814

Substantially Equivalent

Biomet Manufacturing, LLC

FDA 510(k) clearance K142814 for Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial, Substantially Equivalent on 2015-06-25. Applicant: Biomet Manufacturing, LLC.

Clearance details

Applicant: Biomet Manufacturing, LLC
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 2014-09-29
Decision date: 2015-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.