Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations
Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations (Wyoming): 510(k) cleared for McGinley Orthopaedic Innovations. Its amount of 192 is above the median of 138 (68th percentile). Dated 16 days ago, it is in the active follow-up window. Score 48/100. As of 2026-11-03, 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: 192 · 68th percentile of 414 FDAPulse records · 1.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 0 related WY FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261189 |
| Device | Freedom Nail Ankle Fusion System |
| Applicant | McGinley Orthopaedic Innovations |
| Specialty / panel | Orthopedic |
| Product code | HSB |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-10 |
| Decision date | 2026-10-19 |
| Review time (days) | 192 |
| Third-party review | No |
| Applicant location | Casper, WY, US |
| amount percentile | 68th of 414 (median 138, 1.4x 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: 2026-10-19
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 192-day review, longer than typical.
- Posted 16 days ago.
What is the FDAPulse record for Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations in Wyoming?
Freedom Nail Ankle Fusion System (K261189) by McGinley Orthopaedic Innovations was cleared on 2026-10-19 after 192 days of review.
How does Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations compare to other Wyoming FDAPulse records?
Its amount of 192 sits in the upper half (68th percentile) of 414 records; the median is 138. It is 16 days old, still within a typical 45-day follow-up window.
Freedom Nail Ankle Fusion System (K261189) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Freedom Nail Ankle Fusion System (K261189) | WY | 2026-10-19 |
| 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 |
Compare Freedom Nail Ankle Fusion System (K261189) vs APEX 3D S Diamond Tibia (K261120) →
Compare Freedom Nail Ankle Fusion System (K261189) vs DynaNail Helix® Fixation System (K260995) →
Related records
- TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC
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- F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
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