DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro
FDA 510(k) K254110 · MedShape, Inc.
510(k) numberK254110
Submission
- Device name
- DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro
- Applicant
- MedShape, Inc.
Atlanta, GA, US - Received
- December 19, 2025
- Decision date
- March 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250628 | DynaNail TTC Fusion SystemHSB · Traditional | 09/12/2025SE |
| 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 Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro cleared by the FDA?
DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (K254110) received a 510(k) decision of Substantially Equivalent on March 18, 2026, 89 days after the submission was received.
What is the product code of K254110?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.