M-Vizion Femoral Revision System Extension (K260173): 510(k) cleared for Medacta International S.A.
M-Vizion Femoral Revision System Extension (K260173): 510(k) cleared for Medacta International S.A.: 510(k) cleared for Medacta International S.A. Its amount of 239 is above the median of 138 (77th percentile). Dated 49 days ago, it serves as a historical benchmark. Score 42/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 239 · 77th percentile of 414 FDAPulse records · 1.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 6 related CH FDAPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 77th of 414 (median 138, 1.7x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-17
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (CH first): ErgoSteel (ES0001/696) (K253762) · DRIM-Nail System (K260115) · CAS-One IR (K261225) · OTOPLAN (K262080) · GMK Extension (K262057) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 21:30:53 GMT
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Peer benchmark and outreach value: M-Vizion Femoral Revision System Extension (K260173): 510(k) cleared for Medacta International S.A. and 7 CH peers
- CH FDAPulse records like this one: 7
- M-Vizion Femoral Revision System Extension (K260173): 510(k) cleared for Medacta International S.A.'s amount: 77th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CH peer: $1,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 239-day review, longer than typical.
What is the FDAPulse record for M-Vizion Femoral Revision System Extension (K260173): 510(k) cleared for Medacta International S.A.?
M-Vizion Femoral Revision System Extension (K260173) by Medacta International S.A. was cleared on 2026-09-17 after 239 days of review.
How does M-Vizion Femoral Revision System Extension (K260173): 510(k) cleared for Medacta International S.A. compare to other FDAPulse records?
Its amount of 239 sits in the upper half (77th percentile) of 414 records; the median is 138. It is 49 days old; check the official source for later updates before acting.
M-Vizion Femoral Revision System Extension (K260173) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| M-Vizion Femoral Revision System Extension (K260173) | CH | 2026-09-17 |
| TruVision Single-Use 1.9mm Arthroscopy System (K260156) | UT | 2026-10-09 |
| Kentrospine Viktr-MIS® Pedicle screw system (K252139) | IN | 2026-09-27 |
| F.A.S.T Screw (K254280) | FR | 2026-09-21 |
Related records
- TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC
- Kentrospine Viktr-MIS® Pedicle screw system (K252139): 510(k) cleared for Rivarp Medical Pvt., Ltd.
- F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Orthopedic devices
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