KTT
- Product code
- KTT
- Device name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3030
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 404
510(k) clearances, last 3 years (23)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254087 | 2026-06-11 | Synthes (USA) Products, LLC | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Corre | |
| K260900 | 2026-04-17 | Vilex, LLC | DYNEX® External Fixation Systems | |
| K260112 | 2026-03-23 | Stabiliz Orthopaedics, Inc. | QuikFix External Fixator: Knee-Spanning Pack | |
| K253291 | 2026-01-20 | Blue Ocean Global | Excelsior System | |
| K253613 | 2025-12-19 | Paragon 28, Inc. | Monkey Rings External Ring Fixation System | |
| K253202 | 2025-12-19 | Stryker GmbH | Hoffmann LRF System | |
| K252555 | 2025-11-25 | Medusa Orthopedics, LLC | Medusa Orthopedics Boa External Fixation System | |
| K252625 | 2025-11-20 | Response Ortho Solutions, LLC | The Response Ortho Smart Fixator - Hexapod System | FDA |
| K252106 | 2025-09-30 | Paragon 28, Inc. | External Fixation Mini Rail System | |
| K251862 | 2025-08-11 | Paragon 28, Inc. | External Fixation Bone Distractor | |
| K250472 | 2025-08-08 | Amdt Holdings, Inc. | SixFix Hexapod Fixator and Deformity Analysis and C | |
| K251128 | 2025-05-07 | Extremity Medical, LLC | Extremity Medical External Fixation System | |
| K243798 | 2025-03-07 | OrthoPediatrics Corp. | Orthex External Fixation System | |
| K241563 | 2025-02-21 | Extremity Medical, LLC | Extremity Medical External Fixation System | |
| K242861 | 2024-12-03 | Orthofix Srl | TrueLok Elevate | |
| K242452 | 2024-11-01 | Paragon 28, Inc. | Monkey Bars Pin to Bar External Fixation System | |
| K241769 | 2024-09-18 | Response Ortho Solutions, LLC | Response Ortho Metaphyseal Hinge Fixator System | |
| K233025 | 2024-05-30 | New Standard Device Dba Metalogix | Revolution External Plating System | |
| K240049 | 2024-05-29 | Metric Medical Devices, Inc. | LINK(TM) External Fixator | |
| K233741 | 2023-12-21 | Stryker GmbH | Hoffmann LRF System | |
| K221787 | 2023-11-30 | Auxein Medical Private Limited | Auxein's DHS/DCS Plate System | |
| K232897 | 2023-10-18 | Arthrex, Inc. | Arthrex Small External Fixation System | |
| K232838 | 2023-10-12 | Paragon 28, Inc. | Monkey RingsTM External Fixation System |
Official FDA classification page: KTT
Classification and pathway per current FDA publications. Data from openFDA (CC0).