SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES— 510(k) K042895

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K042895 for SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES, Substantially Equivalent on 2004-11-16. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2004-10-20
Decision date: 2004-11-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Paoli, PA, US

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Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.