TMC Implant Fixation System (K262963): 510(k) cleared for Treace Medical Concepts, Inc.
TMC Implant Fixation System (K262963): 510(k) cleared for Treace Medical Concepts, Inc. (Florida): 510(k) cleared for Treace Medical Concepts, Inc. Its amount of 21 is below the median of 138 (1st percentile). Dated 50 days ago, it serves as a historical benchmark. Score 35/100. 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: 21 · 1th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 15 related FL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262963 |
| Device | TMC Implant Fixation System |
| Applicant | Treace Medical Concepts, Inc. |
| Specialty / panel | Orthopedic |
| Product code | HRS |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-08-25 |
| Decision date | 2026-09-15 |
| Review time (days) | 21 |
| Third-party review | No |
| Applicant location | Ponte Vedra, FL, US |
| amount percentile | 1th of 414 (median 138, 0.2x median) |
| Peer records CSV (16 FL 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: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (FL first): Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · Hemotag Analysis Software (HAS) (K252736) · Durashield Device Kit (K252995) · epi-ConneKt Wound Matrix (K260530) · BellaTek Bars (K260940) · Browse all by state and category →
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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Peer benchmark and outreach value: TMC Implant Fixation System (K262963): 510(k) cleared for Treace Medical Concepts, Inc. and 16 Florida peers
- Florida FDAPulse records like this one: 16
- TMC Implant Fixation System (K262963): 510(k) cleared for Treace Medical Concepts, Inc.'s amount: 1st percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Florida peer: $3,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
35 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 21-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
What is the FDAPulse record for TMC Implant Fixation System (K262963): 510(k) cleared for Treace Medical Concepts, Inc. in Florida?
TMC Implant Fixation System (K262963) by Treace Medical Concepts, Inc. was cleared on 2026-09-15 after 21 days of review.
How does TMC Implant Fixation System (K262963): 510(k) cleared for Treace Medical Concepts, Inc. compare to other Florida FDAPulse records?
Its amount of 21 is below the median (1th percentile); smaller records often move faster and face less competition. It is 50 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 35/100 is modest; treat it as background rather than a priority.
TMC Implant Fixation System (K262963) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| TMC Implant Fixation System (K262963) | FL | 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 |
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