JDR
- Product code
- JDR
- Device name
- Staple, Fixation, Bone
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3030
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 10 (direct download)
- 510(k) clearances (all years, FDA)
- 232 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261121 | 2026-08-06 | Paragon 28, Inc. | Megalodon Dynamic Compression System | |
| K250712 | 2025-05-14 | Trax Surgical | Linkt Compression Staple System | |
| K243888 | 2025-04-11 | Medline Industries, LP | Medline UNITE® REFLEX® Hybrid Nitinol Implant Syst… | |
| K243742 | 2025-01-31 | Arthrex, Inc. | Arthrex DynaNite Nitinol Staples | |
| K243658 | 2024-12-26 | Treace Medical Concepts | TMC Compression Implant System | |
| K242415 | 2024-09-06 | Treace Medical Concepts | TMC Compression Implant System | |
| K240212 | 2024-02-23 | Ortho Solutions UK , Ltd. | COGNiTiON Staple System | |
| K232990 | 2024-01-12 | Rmr Ortho, LLC | ATOMIC Nitinol Fixation System | |
| K230724 | 2023-12-04 | Novastep | arcad® 2.0 Duo & Quadro osteosynthesis compressive s… | |
| K232905 | 2023-10-19 | Medline Industries, LP | Medline UNITE® REFLEX® Nitinol Staple Kit |
Official FDA classification page: JDR
Classification and pathway per current FDA publications. Data from openFDA (CC0).