External Fixation Mini Rail System
FDA 510(k) K252106 · Paragon 28, Inc.
510(k) numberK252106
Submission
- Device name
- External Fixation Mini Rail System
- Applicant
- Paragon 28, Inc.
Englewood, CO, US - Received
- July 3, 2025
- Decision date
- September 30, 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
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|---|---|---|---|
| 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 |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| 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 |
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| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | 08/28/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | 08/06/2026SE |
| K262047 | Grappler Suture Anchor SystemMBI · Special | 08/03/2026SE |
| K253886 | Grappler Suture Anchor PCFD Tether SystemMBI · Traditional | 03/17/2026SE |
| K253591 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Traditional | 03/05/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | 12/19/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | 08/11/2025SE |
| K250952 | Baby Gorilla®/Gorilla® Plating SystemHRS · Traditional | 07/18/2025SE |
| K251850 | Phantom® Hindfoot TTC/TC Nail SystemHSB · Special | 07/14/2025SE |
| K250641 | APEX 3D Total Ankle Replacement SystemHSN · Traditional | 05/01/2025SE |
Questions and answers
When was External Fixation Mini Rail System cleared by the FDA?
External Fixation Mini Rail System (K252106) received a 510(k) decision of Substantially Equivalent on September 30, 2025, 89 days after the submission was received.
What is the product code of K252106?
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.