GMK Extension (K262057): 510(k) cleared for Medacta International SA
GMK Extension (K262057): 510(k) cleared for Medacta International SA: 510(k) cleared for Medacta International SA. Its amount of 89 is below the median of 138 (29th percentile). Dated 51 days ago, it serves as a historical benchmark. Score 30/100. 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: 89 · 29th percentile of 414 FDAPulse records · 0.6x 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 | K262057 |
| Device | GMK Extension |
| Applicant | Medacta International SA |
| Specialty / panel | Orthopedic |
| Product code | JWH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-18 |
| Decision date | 2026-09-15 |
| Review time (days) | 89 |
| Third-party review | No |
| Applicant location | Castel San Pietro, CH |
| amount percentile | 29th of 414 (median 138, 0.6x median) |
| Peer records CSV (7 CH records) | 🔒 Click to unlock → |
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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: 2026-09-15
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (CH first): ErgoSteel (ES0001/696) (K253762) · DRIM-Nail System (K260115) · M-Vizion Femoral Revision System Extension (K260173) · CAS-One IR (K261225) · OTOPLAN (K262080) · 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 09:16:12 GMT
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Peer benchmark and outreach value: GMK Extension (K262057): 510(k) cleared for Medacta International SA and 7 CH peers
- CH FDAPulse records like this one: 7
- GMK Extension (K262057): 510(k) cleared for Medacta International SA's amount: 29th 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)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 89-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for GMK Extension (K262057): 510(k) cleared for Medacta International SA?
GMK Extension (K262057) by Medacta International SA was cleared on 2026-09-15 after 89 days of review.
How does GMK Extension (K262057): 510(k) cleared for Medacta International SA compare to other FDAPulse records?
Its amount of 89 is below the median (29th percentile); smaller records often move faster and face less competition. It is 51 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
GMK Extension (K262057) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| GMK Extension (K262057) | CH | 2026-09-15 |
| 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
- The VEGA Cervical Screw System (K254260): 510(k) cleared for GS Medical Co., Ltd.
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- Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations
- APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc.
- Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp.
- DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc.
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- Tempo Plating System (K263407): 510(k) cleared for Pace Surgical
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Orthopedic devices
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