FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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)
K Number: K250929
·
Decision Jun 26, 2025
Classifications
1
FEI Numbers
505
Registration Numbers
505
Same Product Code
1254
Applicant Total
19
Review Days
90
Basic Information
- Device Name
- 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)
- K Number
- K250929
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- TriMed, Inc.
- Date Received
- March 28, 2025
- Decision Date
- June 26, 2025
- 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
Other 510(k) clearances with the same product code (HRS), ordered by most recent decision date.
TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
FDA 510(k)
FDA Class 2
·Orthopedic
Genostis Osteosynthesis System
FDA 510(k)
FDA Class 2
·Orthopedic
Equinoxe® Scapula Fracture System
FDA 510(k)
FDA Class 2
·Orthopedic
LORRAINE 2.5/3.5mm Distal Humerus System
FDA 510(k)
FDA Class 2
·Orthopedic
Montblanc Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
ARIX Pectus Bar System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by TriMed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251134 | RipCord | Jul 11, 2025 | Substantially Equivalent |
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | Jul 10, 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 |
| K243569 | TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs); | Jan 15, 2025 | Substantially Equivalent |
| K243050 | TriMed Posterior Malleolus Fixation System | Nov 26, 2024 | Substantially Equivalent |
| K241942 | TriMed Bridge Plates | Sep 17, 2024 | Substantially Equivalent |