FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Arthrex Nano FiberTak Suture Anchor
K Number: K254229
·
Decision Mar 2, 2026
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
348
Review Days
63
Basic Information
- Device Name
- Arthrex Nano FiberTak Suture Anchor
- K Number
- K254229
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrex, Inc.
- Date Received
- December 29, 2025
- Decision Date
- March 2, 2026
- Product Code
- MBI
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Arthrex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253931 | Arthrex Bioabsorbable PushLock Suture Anchors | May 28, 2026 | Substantially Equivalent |
| K254215 | Arthrex Beaming System | May 8, 2026 | Substantially Equivalent |
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| K260561 | Arthrex FiberTak Suture Anchor | Mar 20, 2026 | Substantially Equivalent |
| K260405 | FiberTape Button | Mar 9, 2026 | Substantially Equivalent |
| K252196 | Arthrex FibuLock Nail System | Mar 5, 2026 | Substantially Equivalent |
| K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Mar 3, 2026 | Substantially Equivalent |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Jan 21, 2026 | Substantially Equivalent |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Jan 12, 2026 | Substantially Equivalent |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | Dec 30, 2025 | Substantially Equivalent |