DynaClip Bone Staple
FDA 510(k) K193305 · MedShape, Inc.
510(k) numberK193305
Submission
- Device name
- DynaClip Bone Staple
- Applicant
- MedShape, Inc.
Atlanta, GA, US - Received
- November 29, 2019
- Decision date
- April 23, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDR – Staple, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K262451 | Arthrex DynaNite StaplesJDR · Traditional | Arthrex, Inc. | 09/01/2026SE |
| K261121 | Megalodon Dynamic Compression SystemJDR · Traditional | Paragon 28, Inc. | 08/06/2026SE |
| K250712 | Linkt Compression Staple SystemJDR · Traditional | Trax Surgical | 05/14/2025SE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemJDR · Traditional | Medline Industries, LP | 04/11/2025SE |
| K243742 | Arthrex DynaNite Nitinol StaplesJDR · Traditional | Arthrex, Inc. | 01/31/2025SE |
| K243658 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 12/26/2024SE |
| K242415 | TMC Compression Implant SystemJDR · Special | Treace Medical Concepts | 09/06/2024SE |
| K240212 | COGNiTiON Staple SystemJDR · Special | Ortho Solutions UK , Ltd. | 02/23/2024SE |
| K232990 | ATOMIC Nitinol Fixation SystemJDR · Traditional | Rmr Ortho, LLC | 01/12/2024SE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesJDR · Traditional | Novastep | 12/04/2023SE |
More from Novastep
| 510(k) | Device | Decision |
|---|---|---|
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…HWC · Traditional | 03/18/2026SE |
| 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 |
| 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 DynaClip Bone Staple cleared by the FDA?
DynaClip Bone Staple (K193305) received a 510(k) decision of Substantially Equivalent on April 23, 2020, 146 days after the submission was received.
What is the product code of K193305?
The FDA product code is JDR – Staple, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.