FDA Product Code
FDA Product Code JDR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3030
510(k) Clearances — 233 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262451 | Arthrex DynaNite Staples | Arthrex, Inc. | 2026-09-01 | Traditional | PDF ↗ |
| K261121 | Megalodon Dynamic Compression System | Paragon 28, Inc. | 2026-08-06 | Traditional | PDF ↗ |
| K250712 | Linkt Compression Staple System | Trax Surgical | 2025-05-14 | Traditional | PDF ↗ |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | 2025-04-11 | Traditional | PDF ↗ |
| K243742 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2025-01-31 | Traditional | PDF ↗ |
| K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024-12-26 | Special | PDF ↗ |
| K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024-09-06 | Special | PDF ↗ |
| K240212 | COGNiTiON Staple System | Ortho Solutions UK , Ltd. | 2024-02-23 | Special | PDF ↗ |
| K232990 | ATOMIC Nitinol Fixation System | Rmr Ortho, LLC | 2024-01-12 | Traditional | PDF ↗ |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Novastep | 2023-12-04 | Traditional | PDF ↗ |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP | 2023-10-19 | Special | PDF ↗ |
| K232324 | StealthFix Intraosseous Fixation System | Medartis, Inc. | 2023-08-30 | Special | PDF ↗ |
| K232387 | Treace Medical Concepts (TMC) Compression Implant System | Treace Medical Concepts | 2023-08-28 | Special | PDF ↗ |
| K231493 | NITINEX Memory Compression Staple | Vilex, LLC | 2023-08-11 | Traditional | PDF ↗ |
| K231885 | Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP | 2023-08-09 | Traditional | PDF ↗ |
| K231458 | Extremity Staple | Restor3D | 2023-08-03 | Traditional | PDF ↗ |
| K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023-05-11 | Traditional | PDF ↗ |
| K223056 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023-02-16 | Traditional | PDF ↗ |
| K222645 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2022-11-21 | Traditional | PDF ↗ |
| K221947 | Tyber Medical Staple Fixation System (various) | Tyber Medical, LLC | 2022-10-20 | Traditional | PDF ↗ |
| K220812 | DynaClip® Bone Staple | MedShape, Inc. | 2022-08-19 | Traditional | PDF ↗ |
| K210582 | EasyClip® and EasyClip® Xpress | Stryker GmbH | 2022-06-10 | Traditional | PDF ↗ |
| K220181 | StealthFix Intraosseous Fixation System | Nextremity Solutions, Inc. | 2022-03-22 | Traditional | PDF ↗ |
| K203832 | FuseForce Flex Dynamic Compression System | Wright Medical | 2021-05-07 | Traditional | PDF ↗ |
| K210482 | Medline UNITE REFLEX Nitinol Staple System | Medline Industries, Inc. | 2021-04-22 | Traditional | PDF ↗ |
| K210456 | Ligament Staple | Medacta International S.A. | 2021-04-12 | Traditional | PDF ↗ |
| K203180 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2020-12-16 | Traditional | PDF ↗ |
| K193305 | DynaClip Bone Staple | MedShape, Inc. | 2020-04-23 | Traditional | PDF ↗ |
| K192447 | Superelastic Staple | Neosteo | 2020-02-28 | Traditional | PDF ↗ |
| K191463 | DePuy Synthes Hammertoe Continuous Compression Implant | Synthes (USA) Products, LLC | 2020-02-26 | Traditional | PDF ↗ |
| K190722 | TriMAX Implant System | Crossroads Extemity Systems, LLC | 2019-08-16 | Traditional | PDF ↗ |
| K191636 | APTUS Foot System | Medartis AG | 2019-08-16 | Traditional | PDF ↗ |
| K190166 | TriMed Nitinol Staple System | TriMed, Inc. | 2019-07-01 | Traditional | PDF ↗ |
| K182943 | VERTEX Nitinol Staple System | Nvision Biomedical Technologies, LLC | 2019-04-04 | Traditional | PDF ↗ |
| K182212 | Geo Staple System | Gramercy Extremity Orthopedics, LLC | 2019-01-11 | Traditional | PDF ↗ |
| K181781 | DynaClipTM Bone Staple | MedShape, Inc. | 2018-11-05 | Traditional | PDF ↗ |
| K181815 | DynaBridge | Fusion Orthopedics, LLC | 2018-10-15 | Traditional | PDF ↗ |
| K181866 | MotoCLIP/HiMAX Step Staple Implant System | Crossroads Extremity Systems, LLC | 2018-08-09 | Special | PDF ↗ |
| K180544 | DePuy Synthes Static Staples | Synthes (USA) Products, LLC | 2018-07-24 | Traditional | PDF ↗ |
| K181410 | MotoCLIP/HiMAX Implant System | Crossroads Extremity Systems, LLC | 2018-06-29 | Special | PDF ↗ |
| K173775 | Clench Compression Staple | F & A Foundation, LLC D.B.A. Reign Medical | 2018-04-06 | Traditional | PDF ↗ |
| K173693 | Orbitum Bone Staple Implant, X and VI | Orthovestments, LLC | 2018-02-23 | Traditional | PDF ↗ |
| K172205 | ExoToe Staple | Exotoe, LLC | 2018-01-11 | Traditional | PDF ↗ |
| K172052 | Arthrex DynaNite Nitinol Staple | Arthrex, Inc. | 2017-12-13 | Traditional | PDF ↗ |
| K172405 | SNIPER STAPLE SYSTEM, NON-STERILE | Trilliant Surgical | 2017-12-11 | Traditional | PDF ↗ |
| K171473 | Compressyn Staple | Dallen Medical, Inc. | 2017-11-07 | Traditional | PDF ↗ |
| K170923 | JAWS(TM) Nitinol Staple System | Paragon 28 | 2017-07-24 | Traditional | PDF ↗ |
| K163226 | EPIC Extremely Small Staple | Epic Extremely, LLC | 2017-05-16 | Traditional | PDF ↗ |
| K162354 | Sniper Staple System | Trilliant Surgical, Ltd. | 2017-04-20 | Traditional | PDF ↗ |
| K162321 | EasyClip Xpress | Restore Surgical, LLC Dba Instratek | 2017-02-10 | Traditional | PDF ↗ |
| K161587 | Memodyn Staple | Austin & Associates, Inc./Telos Medical Equipment | 2017-02-01 | Special | PDF ↗ |
| K163440 | Stealth Staple System | First Ray, LLC | 2017-02-01 | Traditional | PDF ↗ |
| K161426 | NeoSpan Compression Staple Impant w/instruments | In2bones USA, LLC | 2016-10-24 | Traditional | PDF ↗ |
| K160813 | EasyStep | Stryker GmbH | 2016-07-26 | Traditional | PDF ↗ |
| K153622 | First Ray Internal Bone Staple System | First Ray, LLC | 2016-04-08 | Traditional | PDF ↗ |
| K153770 | OS2(R)-VP Varisation Staple | In2bones Sas | 2016-03-21 | Traditional | PDF ↗ |
| K153395 | OS2-C Compression Staple | In2bones Sas | 2016-02-18 | Traditional | PDF ↗ |
| K153129 | dynaMX Tabbed Staple | Mx Orthopedics, Corp. | 2016-01-28 | Traditional | PDF ↗ |
| K151762 | PediatrOS RigidTack/FlexTack | Merete Medical GmbH | 2015-12-28 | Traditional | PDF ↗ |
| K151615 | TiTHON Staple with OsseoTi Technology | Biomet Manufacturing Corp | 2015-10-02 | Traditional | PDF ↗ |
| K151160 | Arcus Staple System | Nextremity Solutions, Inc. | 2015-09-04 | Traditional | PDF ↗ |
| K143622 | dynaMX Compression Staple | Mx Orthopedics, Corp. | 2015-06-17 | Traditional | PDF ↗ |
| K150125 | Elite Nitinol Fixation System | Biomedical Enterprises, Inc. | 2015-05-11 | Traditional | PDF ↗ |
| K143323 | OS2-V Varisation Staple | In2bones Sas | 2015-02-26 | Traditional | PDF ↗ |
| K143037 | SnapShot Fixation System | Biomet Manufacturing Corp | 2015-01-20 | Traditional | PDF ↗ |
| K142111 | ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE | Novatsep | 2014-12-19 | Traditional | PDF ↗ |
| K141263 | TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS | Biomet Manufacturing Corp | 2014-11-19 | Traditional | PDF ↗ |
| K142292 | Speed, Speed Shift, Speed Titan, Speed Arc | Biomedical Enterprises, Inc. | 2014-11-17 | Traditional | PDF ↗ |
| K142727 | CrossCLIP Implant System | Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems | 2014-10-24 | Traditional | PDF ↗ |
| K142148 | ORTHOHELIX STAPLE SYSTEM | Orthohelix Surgical Designs, Inc. | 2014-08-21 | Special | PDF ↗ |
| K141550 | INSTAFIX SHAPE MEMORY FIXATION SYSTEM | Ot Medical | 2014-07-11 | Special | PDF ↗ |
| K140358 | COMPRESSYN STAPLE | Dallen Medical, Inc. | 2014-06-02 | Traditional | PDF ↗ |
| K133270 | SPEED ARC | Biomedical Enterprises, Inc. | 2014-04-17 | Traditional | PDF ↗ |
| K133844 | SPEED TRIAD | Biomedical Ent., Inc. | 2014-04-07 | Special | PDF ↗ |
| K133780 | SPEED XL | Biomedical Ent., Inc. | 2014-03-19 | Traditional | PDF ↗ |
| K133523 | STAPIX SUPERELASTIC IMPLANT BONE STAPLES | Instratek, Inc. | 2014-02-06 | Traditional | PDF ↗ |
| K132875 | COMPRESSYN STAPLE | Dallen Medical, Inc. | 2013-12-30 | Traditional | PDF ↗ |
| K131061 | RESTORE BUNION CORRECTION SYSTEM | Nextremity Solutions | 2013-08-28 | Traditional | PDF ↗ |
| K130832 | ORTHOHELIX STAPLE SYSTEM | Orthohelix Surgical Designs, Inc. | 2013-08-15 | Traditional | PDF ↗ |
| K124045 | FUSEFORCE IMPLANT SYSTEM | Solana Surgical, LLC | 2013-07-10 | Traditional | PDF ↗ |
| K124022 | SPEED SHIFT | Biomedical Enterprises, Inc. | 2013-05-14 | Traditional | PDF ↗ |
| K123926 | METASURG NITINOL STAPLE IMPLANT | Metasurg | 2013-05-03 | Traditional | PDF ↗ |
| K122113 | MEMORY METAL STAPLES, EASYCLIP | Stryker Corp. | 2013-03-12 | Traditional | PDF ↗ |
| K122871 | COMPRESSYN STAPLE | Dallen Medical, Inc. | 2013-02-07 | Traditional | PDF ↗ |
| K123363 | SUPER STAPLE(TM) CLASSIC | Metric Medical Devices, Inc. | 2013-01-03 | Traditional | PDF ↗ |
| K112837 | VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) | Vilex, Inc. | 2012-10-09 | Traditional | PDF ↗ |
| K102387 | MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES | Mediscope Manufacturing, Inc. | 2011-10-24 | Traditional | PDF ↗ |
| K102143 | SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM | Suspension Orthopaedic Solutions, LLC | 2010-12-08 | Traditional | PDF ↗ |
| K102107 | OSSTAPLE CHILL | Biomedical Ent., Inc. | 2010-09-03 | Special | PDF ↗ |
| K082215 | OSTEORAPTOR SUTURE ANCHOR | Smith & Nephew Inc., Endoscopy Division | 2008-11-03 | Traditional | PDF ↗ |
| K081172 | COMPOSITE HITCH SUTURE ANCHOR | Biomet Manufacturing Corp | 2008-07-17 | Traditional | PDF ↗ |
| K081098 | ENDOBUTTON CONTINUOUS LOOP (CL) | Smith & Nephew Inc., Endoscopy Division | 2008-07-16 | Traditional | PDF ↗ |
| K073281 | CAIS STAPLE | Depuy Mitek, A Johnson & Johnson Company | 2008-05-02 | Traditional | PDF ↗ |
| K080111 | ARTHREX COMPRESSION STAPLE | Arthrex, Inc. | 2008-02-13 | Traditional | PDF ↗ |
| K072298 | BIOPRO MEMORY STAPLE, MODELS 18062-18073 | Biopro, Inc. | 2007-10-29 | Traditional | PDF ↗ |
| K071477 | REVERTO 55 AND 37 SHAPE MEMORY STAPLES | Core Essence Orthopaedics, LLC | 2007-08-15 | Traditional | PDF ↗ |
| K071637 | INTRINSIC THERAPEUTICS FIXATION STAPLE | Intrinsic Therapeutics Incorporated | 2007-08-03 | Traditional | PDF ↗ |
| K071479 | SBI STAFIX | Small Bone Innovations, Inc. | 2007-08-02 | Traditional | PDF ↗ |
| K071257 | MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD | Depuy Mitek, A Johnson & Johnson Company | 2007-06-29 | Traditional | PDF ↗ |
| K070688 | NEXFIX COMPRESSION STAPLE | Nexa Orthopedics, Inc. | 2007-05-18 | Traditional | PDF ↗ |
Product code JDR · Class II · Orthopedic. Data: openFDA.