Mpact 3D Metal Foam— 510(k) K253630
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K253630 for Mpact 3D Metal Foam, Substantially Equivalent on 2026-08-28. Applicant: Medacta International S.A.. Device class: 2.
Summary
Medacta International's Mpact 3D Metal Foam is filed under product code LPH: hip prosthesis, semi-constrained, metal/polymer, porous uncemented. The record doesn't describe the device beyond its name and that code.
Class II, 21 CFR 888.3358. Orthopedic is both the classification panel and the review panel, and it was a Traditional 510(k).
Medacta filed from Castel San Pietro, Switzerland. The substantially equivalent decision came 282 calendar days after receipt (November 19, 2025 to August 28, 2026).
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Product code LPH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro, CH
Recent devices under product code LPH
view allMore clearances from Medacta International S.A.
view allAdverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
Source: openFDA MAUDE database, through . 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.