JDR · Staple, Fixation, Bone
Orthopedic · 21 CFR 888.3030 · Class 2
Overview
| Product Code | JDR |
|---|---|
| Device Name | Staple, Fixation, Bone |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 231)
Showing 20 most recent of 231 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250712 | Linkt Compression Staple System | Trax Surgical | May 14, 2025 | SESE |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | Apr 11, 2025 | SESE |
| K243742 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | Jan 31, 2025 | SESE |
| K243658 | TMC Compression Implant System | Treace Medical Concepts | Dec 26, 2024 | SESE |
| K242415 | TMC Compression Implant System | Treace Medical Concepts | Sep 6, 2024 | SESE |
| K240212 | COGNiTiON Staple System | Ortho Solutions UK , Ltd. | Feb 23, 2024 | SESE |
| K232990 | ATOMIC Nitinol Fixation System | Rmr Ortho, LLC | Jan 12, 2024 | SESE |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Novastep | Dec 4, 2023 | SESE |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP | Oct 19, 2023 | SESE |
| K232324 | StealthFix Intraosseous Fixation System | Medartis, Inc. | Aug 30, 2023 | SESE |
| K232387 | Treace Medical Concepts (TMC) Compression Implant System | Treace Medical Concepts | Aug 28, 2023 | SESE |
| K231493 | NITINEX Memory Compression Staple | Vilex, LLC | Aug 11, 2023 | SESE |
| K231885 | Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP | Aug 9, 2023 | SESE |
| K231458 | Extremity Staple | Restor3D | Aug 3, 2023 | SESE |
| K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | May 11, 2023 | SESE |
| K223056 | JAWS Nitinol Staple System | Paragon 28, Inc. | Feb 16, 2023 | SESE |
| K222645 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | Nov 21, 2022 | SESE |
| K221947 | Tyber Medical Staple Fixation System (various) | Tyber Medical, LLC | Oct 20, 2022 | SESE |
| K220812 | DynaClip® Bone Staple | MedShape, Inc. | Aug 19, 2022 | SESE |
| K210582 | EasyClip® and EasyClip® Xpress | Stryker GmbH | Jun 10, 2022 | SESE |
Top Applicants
- Mitek Surgical Products, Inc. — 16 clearances
- Acufex Microsurgical, Inc. — 9 clearances
- Depuy Mitek, A Johnson & Johnson Company — 7 clearances
- Biomedical Ent., Inc. — 6 clearances
- Howmedica Corp. — 5 clearances
