M-Vizion Femoral Revision System Extension— 510(k) K260173
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K260173 for M-Vizion Femoral Revision System Extension, Substantially Equivalent on 2026-09-17. Applicant: Medacta International S.A.. Device class: 2.
Summary
Medacta International S.A. filed the M-Vizion Femoral Revision System Extension under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented). The record doesn't list the components the submission covers.
Class II, 21 CFR 888.3353. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Medacta filed from Castel San Pietro, Switzerland. The decision came 239 calendar days after FDA received it (January 21 to September 17, 2026).
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Product code LZO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro, CH
Recent devices under product code LZO
view allMore clearances from Medacta International S.A.
view allAdverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
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.