K251166
- 510(k) number
- K251166
- Device name
- Mfinity Femoral System
- Applicant
- Medacta International S.A. CH
- Product code
- MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal
- Decision date
- 2025-06-13
- Date received
- 2025-04-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K251166.pdf
Official FDA record: K251166
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.