FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)
K Number: K254002
·
Decision Jan 15, 2026
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
36
Review Days
31
Basic Information
- Device Name
- TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S)
- K Number
- K254002
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TriMed, Inc.
- Date Received
- December 15, 2025
- Decision Date
- January 15, 2026
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by TriMed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261241 | TriMed Compression Screws | May 14, 2026 | Substantially Equivalent |
| K252061 | Distal Xtremities System | Aug 20, 2025 | Substantially Equivalent |
| K251134 | RipCord | Jul 11, 2025 | Substantially Equivalent |
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | Jul 10, 2025 | Substantially Equivalent |
| K250929 | TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) | Jun 26, 2025 | Substantially Equivalent |
| K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) | May 22, 2025 | Substantially Equivalent |
| K243943 | TriMed® Compression Screws | Apr 10, 2025 | Substantially Equivalent |
| K250948 | TriMed Fusion Cup System | Apr 8, 2025 | Substantially Equivalent |
| K243987 | TriMed Elbow and Forearm System | Mar 19, 2025 | Substantially Equivalent |
| K243999 | TriMed Ankle Fixation System | Mar 19, 2025 | Substantially Equivalent |