DynaNail TTC Fusion System
FDA 510(k) K250628 · MedShape, Inc.
510(k) numberK250628
Submission
- Device name
- DynaNail TTC Fusion System
- Applicant
- MedShape, Inc.
Atlanta, GA, US - Received
- March 3, 2025
- Decision date
- September 12, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | Stryker GmbH | 06/29/2026SE |
| K261651 | Precice Max System and Precice Ankle Salvage SystemHSB · Special | NuVasive Specialized Orthopedics | 06/18/2026SE |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
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| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
| K260146 | Fitbone® Transport and Lengthening SystemHSB · Traditional | Orthofix Srl | 05/19/2026SE |
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| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…HWC · Traditional | 03/18/2026SE |
| K240530 | DynaNail Mini Tapered HybridHWC · Special | 03/21/2024SE |
| K220812 | DynaClip® Bone StapleJDR · Traditional | 08/19/2022SE |
| K203595 | DynaFuse Fixation SystemHWC · Traditional | 01/04/2022SE |
| K203381 | Dynanail Mini HybridHWC · Traditional | 01/15/2021SE |
| K193305 | DynaClip Bone StapleJDR · Traditional | 04/23/2020SE |
| K182677 | DynaNail MiniHWC · Traditional | 02/14/2019SE |
| K181781 | DynaClipTM Bone StapleJDR · Traditional | 11/05/2018SE |
| K171376 | DynaNail TTC Fusion SystemHSB · Traditional | 11/02/2017SE |
| K141420 | FastforwardHTN · Traditional | 12/18/2014SE |
Questions and answers
When was DynaNail TTC Fusion System cleared by the FDA?
DynaNail TTC Fusion System (K250628) received a 510(k) decision of Substantially Equivalent on September 12, 2025, 193 days after the submission was received.
What is the product code of K250628?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.