Product code JDR
- Device name
- Staple, Fixation, Bone
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3030
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250712 | Linkt Compression Staple System | Trax Surgical | 2025-05-14 |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | 2025-04-11 |
| K243742 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2025-01-31 |
| K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024-12-26 |
| K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024-09-06 |
| K240212 | COGNiTiON™ Staple System | Ortho Solutions UK , Ltd. | 2024-02-23 |
| K232990 | A’TOMIC™ Nitinol Fixation System | Rmr Ortho, LLC | 2024-01-12 |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Novastep | 2023-12-04 |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP | 2023-10-19 |
| K232324 | StealthFix Intraosseous Fixation System | Medartis, Inc. | 2023-08-30 |
| K232387 | Treace Medical Concepts (TMC) Compression Implant System | Treace Medical Concepts | 2023-08-28 |
| K231493 | NITINEX Memory Compression Staple | Vilex, LLC | 2023-08-11 |
| K231885 | Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP | 2023-08-09 |
| K231458 | Extremity Staple | Restor3D | 2023-08-03 |
| K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023-05-11 |
| K223056 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023-02-16 |
| K222645 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2022-11-21 |
| K221947 | Tyber Medical Staple Fixation System (various) | Tyber Medical, LLC | 2022-10-20 |
| K220812 | DynaClip® Bone Staple | MedShape, Inc. | 2022-08-19 |
| K210582 | EasyClip® and EasyClip® Xpress | Stryker GmbH | 2022-06-10 |
| K220181 | StealthFix Intraosseous Fixation System | Nextremity Solutions, Inc. | 2022-03-22 |
| K203832 | FuseForce™ Flex Dynamic Compression System | Wright Medical | 2021-05-07 |
| K210482 | Medline UNITE REFLEX Nitinol Staple System | Medline Industries, Inc. | 2021-04-22 |
| K210456 | Ligament Staple | Medacta International S.A. | 2021-04-12 |
| K203180 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2020-12-16 |
| K193305 | DynaClip Bone Staple | MedShape, Inc. | 2020-04-23 |
| K192447 | Superelastic Staple | Neosteo | 2020-02-28 |
| K191463 | DePuy Synthes Hammertoe Continuous Compression Implant | Synthes (USA) Products, LLC | 2020-02-26 |
| K190722 | TriMAX Implant System | Crossroads Extemity Systems, LLC | 2019-08-16 |
| K191636 | APTUS Foot System | Medartis AG | 2019-08-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630037889397 | APTUS | Medartis AG | 2023-03-03 |
| 07630971238039 | MectaFix CL Fixation Button with Continuous Loop | Medacta International SA | 2020-06-12 |
| 07630971238046 | MectaFix CL Fixation Button with Continuous Loop | Medacta International SA | 2020-06-12 |
| 07630971238053 | MectaFix CL Fixation Button with Continuous Loop | Medacta International SA | 2020-06-12 |
| 07630971238060 | MectaFix CL Fixation Button with Continuous Loop | Medacta International SA | 2020-06-12 |
| 07630971238077 | MectaFix CL Fixation Button with Continuous Loop | Medacta International SA | 2020-06-12 |
| 07630971238084 | MectaFix CL Fixation Button with Continuous Loop | Medacta International SA | 2020-06-12 |
| 07630971238091 | MectaFix CL Fixation Button with Continuous Loop | Medacta International SA | 2020-06-12 |
| 07630971238107 | MectaFix CL Fixation Button with Continuous Loop | Medacta International SA | 2020-06-12 |
| 07630971238114 | MectaFix CL Fixation Button with Continuous Loop | Medacta International SA | 2020-06-12 |
| 07630971238121 | MectaFix CL Fixation Button with Continuous Loop | Medacta International SA | 2020-06-12 |
| 10381780052425 | SOLUSTAPLE | NEWDEAL | 2017-10-09 |
| 10381780052401 | SOLUSTAPLE | NEWDEAL | 2017-10-09 |
| 10381780052388 | SOLUSTAPLE | NEWDEAL | 2017-10-09 |
| 10381780052364 | SOLUSTAPLE | NEWDEAL | 2017-10-09 |
| M224ACL41089 | Inion Hexalon™ ACL/PCL Screw | Inion Oy | 2017-02-07 |
| M224ACL41099 | Inion Hexalon™ ACL/PCL Screw | Inion Oy | 2017-02-07 |
| M224ACL41129 | Inion Hexalon™ ACL/PCL Screw | Inion Oy | 2017-02-07 |
| M224ACL41149 | Inion Hexalon™ ACL/PCL Screw | Inion Oy | 2017-02-07 |
| M224ACL41159 | Inion Hexalon™ ACL/PCL Screw | Inion Oy | 2017-02-07 |
| M224ACL41079 | Inion Hexalon™ ACL/PCL Screw | Inion Oy | 2017-02-07 |
| M224ACL41069 | Inion Hexalon™ ACL/PCL Screw | Inion Oy | 2017-02-07 |
| M224ACL41029 | Inion Hexalon™ ACL/PCL Screw | Inion Oy | 2017-02-07 |
| M224ACL41019 | Inion Hexalon™ ACL/PCL Screw | Inion Oy | 2017-02-07 |
| M224INS920010 | Inion Hexalon instrument | Inion Oy | 2016-08-31 |
| M224INS92009 | Inion Hexalon instrument | Inion Oy | 2016-08-31 |
| M224INS920510 | Inion Hexalon instrument | Inion Oy | 2016-08-31 |
| M224INS92059 | Inion Hexalon instrument | Inion Oy | 2016-08-31 |
| M224INS920610 | Inion Hexalon instrument | Inion Oy | 2016-08-31 |
| M224INS92069 | Inion Hexalon instrument | Inion Oy | 2016-08-31 |