JDR — Staple, Fixation, Bone Class II
FDA product code JDR covers "Staple, Fixation, Bone", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JDR
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262451 | Arthrex | Arthrex DynaNite Staples | Sep 1, 2026 |
| K261121 | Paragon 28 | Megalodon Dynamic Compression System | Aug 6, 2026 |
| K250712 | Trax Surgical | Linkt Compression Staple System | May 14, 2025 |
| K243888 | Medline Industries | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Apr 11, 2025 |
| K243742 | Arthrex | Arthrex DynaNite Nitinol Staples | Jan 31, 2025 |
| K243658 | Treace Medical Concepts | TMC Compression Implant System | Dec 26, 2024 |
| K242415 | Treace Medical Concepts | TMC Compression Implant System | Sep 6, 2024 |
| K240212 | Ortho Solutions Uk | COGNiTiON Staple System | Feb 23, 2024 |
| K232990 | Rmr Ortho | ATOMIC Nitinol Fixation System | Jan 12, 2024 |
| K230724 | Novastep | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Dec 4, 2023 |
| K232905 | Medline Industries | Medline UNITE® REFLEX® Nitinol Staple Kit | Oct 19, 2023 |
| K232324 | Medartis | StealthFix Intraosseous Fixation System | Aug 30, 2023 |
| K232387 | Treace Medical Concepts | Treace Medical Concepts (TMC) Compression Implant System | Aug 28, 2023 |
| K231493 | Vilex | NITINEX Memory Compression Staple | Aug 11, 2023 |
| K231885 | Medline Industries | Medline UNITE® REFLEX® Nitinol Staple System | Aug 9, 2023 |
| K231458 | Restor3D | Extremity Staple | Aug 3, 2023 |
| K230550 | Paragon 28 | JAWS Nitinol Staple System | May 11, 2023 |
| K223056 | Paragon 28 | JAWS Nitinol Staple System | Feb 16, 2023 |
| K222645 | Treace Medical Concepts | Treace Medical Concepts (TMC) Implant Fixation System | Nov 21, 2022 |
| K221947 | Tyber Medical | Tyber Medical Staple Fixation System (various) | Oct 20, 2022 |