FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Orthex External Fixation System
K Number: K243798
·
Decision Mar 7, 2025
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
40
Review Days
86
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Orthex External Fixation System
- K Number
- K243798
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OrthoPediatrics Corp.
- Date Received
- December 11, 2024
- Decision Date
- March 7, 2025
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTT), ordered by most recent decision date.
MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
FDA 510(k)
FDA Class 2
·Orthopedic
DYNEX® External Fixation Systems
FDA 510(k)
FDA Class 2
·Orthopedic
QuikFix External Fixator: Knee-Spanning Pack
FDA 510(k)
FDA Class 2
·Orthopedic
Excelsior System
FDA 510(k)
FDA Class 2
·Orthopedic
Hoffmann LRF System
FDA 510(k)
FDA Class 2
·Orthopedic
Monkey Rings External Ring Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by OrthoPediatrics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | Apr 30, 2026 | Substantially Equivalent |
| K252600 | Pediatric Plating Platform I Small-Mini | Oct 9, 2025 | Substantially Equivalent |
| K251362 | PediFlex Flexible Nail System | Jun 24, 2025 | Substantially Equivalent |
| K243963 | Pediatric Plating Platform Hip | Apr 29, 2025 | Substantially Equivalent |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | Apr 1, 2025 | Substantially Equivalent |
| K241816 | VerteGlide Spinal Growth Guidance System | Mar 14, 2025 | Substantially Equivalent |
| K233105 | RESPONSE Rib and Pelvic System | Jan 20, 2024 | Substantially Equivalent |
| K231266 | Pediatric Nailing Platform Tibia | Aug 21, 2023 | Substantially Equivalent |
| K222105 | RESPONSE 5.5/6.0 Cannulated Screw System | Mar 23, 2023 | Substantially Equivalent |
| K223786 | Orthex External Fixation System | Feb 10, 2023 | Substantially Equivalent |