SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS— 510(k) K051879

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K051879 for SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS, Substantially Equivalent on 2005-10-05. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code FTM
Advisory panel: General, Plastic Surgery
Date received: 2005-07-11
Decision date: 2005-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FTM

product code FTM

Death: 17
Injury: 2,174
Total: 2,191

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.