K253630
- 510(k) number
- K253630
- Device name
- Mpact 3D Metal Foam
- Applicant
- Medacta International S.A. CH
- Product code
- LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Po
- Decision date
- 2026-08-28
- Date received
- 2025-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K253630.pdf
Official FDA record: K253630
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.