GMK 3D Metal Tibial Tray Extension— 510(k) K253328
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K253328 for GMK 3D Metal Tibial Tray Extension, Substantially Equivalent on 2026-02-26. Applicant: Medacta International S.A.. Device class: 2.
Summary
Medacta International's GMK 3D Metal Tibial Tray Extension is filed under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 888.3565. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Medacta filed from Castel San Pietro, Switzerland. The decision came 149 calendar days after FDA received it (September 30, 2025 to February 26, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Product code MBH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3565
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro, CH
Recent devices under product code MBH
view allMore clearances from Medacta International S.A.
view allAdverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
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.