The Response Ortho Smart Fixator - Hexapod System
FDA 510(k) K252625 · Response Ortho Solutions, LLC
510(k) numberK252625
Submission
- Device name
- The Response Ortho Smart Fixator - Hexapod System
- Applicant
- Response Ortho Solutions, LLC
Boca Raton, FL, US - Received
- August 19, 2025
- Decision date
- November 20, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction SystemKTT · Traditional | Synthes (USA) Products, LLC | 06/11/2026SE |
| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
| K250472 | SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)KTT · Traditional | Amdt Holdings, Inc. | 08/08/2025SE |
More from Amdt Holdings, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241769 | Response Ortho Metaphyseal Hinge Fixator SystemKTT · Traditional | 09/18/2024SE |
Questions and answers
When was The Response Ortho Smart Fixator - Hexapod System cleared by the FDA?
The Response Ortho Smart Fixator - Hexapod System (K252625) received a 510(k) decision of Substantially Equivalent on November 20, 2025, 93 days after the submission was received.
What is the product code of K252625?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.