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 |
|---|---|---|---|
| K250712 | trax surgical | Linkt Compression Staple System | May 14, 2025 |
| K243888 | medline industries | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | April 11, 2025 |
| K243742 | arthrex | Arthrex DynaNite Nitinol Staples | January 31, 2025 |
| K243658 | treace medical concepts | TMC Compression Implant System | December 26, 2024 |
| K242415 | treace medical concepts | TMC Compression Implant System | September 6, 2024 |
| K240212 | ortho solutions uk | COGNiTiON Staple System | February 23, 2024 |
| K232990 | rmr ortho | ATOMIC Nitinol Fixation System | January 12, 2024 |
| K230724 | novastep | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | December 4, 2023 |
| K232905 | medline industries | Medline UNITE® REFLEX® Nitinol Staple Kit | October 19, 2023 |
| K232324 | medartis | StealthFix Intraosseous Fixation System | August 30, 2023 |
| K232387 | treace medical concepts | Treace Medical Concepts (TMC) Compression Implant System | August 28, 2023 |
| K231493 | vilex | NITINEX Memory Compression Staple | August 11, 2023 |
| K231885 | medline industries | Medline UNITE® REFLEX® Nitinol Staple System | August 9, 2023 |
| K231458 | restor3d | Extremity Staple | August 3, 2023 |
| K230550 | paragon 28 | JAWS Nitinol Staple System | May 11, 2023 |
| K223056 | paragon 28 | JAWS Nitinol Staple System | February 16, 2023 |
| K222645 | treace medical concepts | Treace Medical Concepts (TMC) Implant Fixation System | November 21, 2022 |
| K221947 | tyber medical | Tyber Medical Staple Fixation System (various) | October 20, 2022 |
| K220812 | medshape | DynaClip® Bone Staple | August 19, 2022 |
| K210582 | stryker | EasyClip® and EasyClip® Xpress | June 10, 2022 |