# M-Vizion Femoral Revision System Extension (K260173): 510(k) cleared for Medacta International S.A.

**Predicate Speed & CAPA Advisory Opportunity Score:** 42/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260173 |
| Device | M-Vizion Femoral Revision System Extension |
| Applicant | Medacta International S.A. |
| Specialty / panel | Orthopedic |
| Product code | LZO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-21 |
| Decision date | 2026-09-17 |
| Review time (days) | 239 |
| Third-party review | No |
| Applicant location | Castel San Pietro, CH |

## Why this score
- 239-day review, longer than typical.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260173). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.