KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Class II
FDA product code KTT covers "Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KTT
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254087 | Synthes (Usa) Products | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | Jun 11, 2026 |
| K260900 | Vilex | DYNEX® External Fixation Systems | Apr 17, 2026 |
| K260112 | Stabiliz Orthopaedics | QuikFix External Fixator: Knee-Spanning Pack | Mar 23, 2026 |
| K253291 | Blue Ocean Global | Excelsior System | Jan 20, 2026 |
| K253202 | Stryker | Hoffmann LRF System | Dec 19, 2025 |
| K253613 | Paragon 28 | Monkey Rings External Ring Fixation System | Dec 19, 2025 |
| K252555 | Medusa Orthopedics | Medusa Orthopedics Boa External Fixation System | Nov 25, 2025 |
| K252625 | Response Ortho Solutions | The Response Ortho Smart Fixator - Hexapod System | Nov 20, 2025 |
| K252106 | Paragon 28 | External Fixation Mini Rail System | Sep 30, 2025 |
| K251862 | Paragon 28 | External Fixation Bone Distractor | Aug 11, 2025 |
| K250472 | Amdt Holdings | SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) | Aug 8, 2025 |
| K251128 | Extremity Medical | Extremity Medical External Fixation System | May 7, 2025 |
| K243798 | Orthopediatrics | Orthex External Fixation System | Mar 7, 2025 |
| K241563 | Extremity Medical | Extremity Medical External Fixation System | Feb 21, 2025 |
| K242861 | Orthofix | TrueLok Elevate | Dec 3, 2024 |
| K242452 | Paragon 28 | Monkey Bars Pin to Bar External Fixation System | Nov 1, 2024 |
| K241769 | Response Ortho Solutions | Response Ortho Metaphyseal Hinge Fixator System | Sep 18, 2024 |
| K233025 | New Standard Device Dba Metalogix | Revolution External Plating System | May 30, 2024 |
| K240049 | Metric Medical Devices | LINK(TM) External Fixator | May 29, 2024 |
| K233741 | Stryker | Hoffmann LRF System | Dec 21, 2023 |