TeKBrace Knotless Anchor (K263352): 510(k) cleared for TheraMicro
TeKBrace Knotless Anchor (K263352): 510(k) cleared for TheraMicro (Tennessee): 510(k) cleared for TheraMicro. Its amount of 28 is below the median of 138 (6th percentile). Dated 14 days ago, it is in the active follow-up window. Score 47/100. 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: 28 · 6th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 8 related TN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263352 |
| Device | TeKBrace Knotless Anchor |
| Applicant | TheraMicro |
| Specialty / panel | Orthopedic |
| Product code | MBI |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-23 |
| Decision date | 2026-10-21 |
| Review time (days) | 28 |
| Third-party review | No |
| Applicant location | Cordova, TN, US |
| amount percentile | 6th of 414 (median 138, 0.2x median) |
| Peer records CSV (9 TN 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: 2026-10-21
- Data refreshed: 2026-11-04
- 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: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: TeKBrace Knotless Anchor (K263352): 510(k) cleared for TheraMicro and 9 Tennessee peers
- Tennessee FDAPulse records like this one: 9
- TeKBrace Knotless Anchor (K263352): 510(k) cleared for TheraMicro's amount: 6th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Tennessee peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
47 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 28-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 14 days ago.
What is the FDAPulse record for TeKBrace Knotless Anchor (K263352): 510(k) cleared for TheraMicro in Tennessee?
TeKBrace Knotless Anchor (K263352) by TheraMicro was cleared on 2026-10-21 after 28 days of review.
How does TeKBrace Knotless Anchor (K263352): 510(k) cleared for TheraMicro compare to other Tennessee FDAPulse records?
Its amount of 28 is below the median (6th percentile); smaller records often move faster and face less competition. It is fresh: dated 14 days ago, inside the window where early outreach matters most.
TeKBrace Knotless Anchor (K263352) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| TeKBrace Knotless Anchor (K263352) | TN | 2026-10-21 |
| 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.
- GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts
- AnyPlus II Spinal Fixation System (K261217): 510(k) cleared for GS Medical Co., Ltd.
- 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.
- Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Co
- Tempo Plating System (K263407): 510(k) cleared for Pace Surgical
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