Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JDR — Predicate Candidate Screening
232 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
313 days90th percentile
232clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261121 | Megalodon Dynamic Compression System | Paragon 28, Inc. | 2026-08-06 | 125 | 0 |
| K250712 | Linkt Compression Staple System | Trax Surgical | 2025-05-14 | 65 | 0 |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | Medline Industries, LP | 2025-04-11 | 114 | 0 |
| K243742 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2025-01-31 | 58 | 0 |
| K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024-12-26 | 29 | 0 |
| K242415 | TMC Compression Implant System | Treace Medical Concepts | 2024-09-06 | 22 | 0 |
| K240212 | COGNiTiON™ Staple System | Ortho Solutions UK , Ltd. | 2024-02-23 | 29 | 0 |
| K232990 | A’TOMIC™ Nitinol Fixation System | Rmr Ortho, LLC | 2024-01-12 | 112 | 0 |
| K230724 | arcad® 2.0 Duo & Quadro osteosynthesis compressive staples | Novastep | 2023-12-04 | 263 | 0 |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | Medline Industries, LP | 2023-10-19 | 30 | 0 |
| K232324 | StealthFix Intraosseous Fixation System | Medartis, Inc. | 2023-08-30 | 27 | 0 |
| K232387 | Treace Medical Concepts (TMC) Compression Implant System | Treace Medical Concepts | 2023-08-28 | 19 | 0 |
| K231493 | NITINEX Memory Compression Staple | Vilex, LLC | 2023-08-11 | 80 | 0 |
| K231885 | Medline UNITE® REFLEX® Nitinol Staple System | Medline Industries, LP | 2023-08-09 | 43 | 0 |
| K231458 | Extremity Staple | Restor3D | 2023-08-03 | 76 | 0 |
| K230550 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023-05-11 | 72 | 0 |
| K223056 | JAWS Nitinol Staple System | Paragon 28, Inc. | 2023-02-16 | 139 | 0 |
| K222645 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts | 2022-11-21 | 81 | 0 |
| K221947 | Tyber Medical Staple Fixation System (various) | Tyber Medical, LLC | 2022-10-20 | 107 | 0 |
| K220812 | DynaClip® Bone Staple | MedShape, Inc. | 2022-08-19 | 151 | 0 |
| K210582 | EasyClip® and EasyClip® Xpress | Stryker GmbH | 2022-06-10 | 469 | 0 |
| K220181 | StealthFix Intraosseous Fixation System | Nextremity Solutions, Inc. | 2022-03-22 | 60 | 0 |
| K203832 | FuseForce™ Flex Dynamic Compression System | Wright Medical | 2021-05-07 | 128 | 0 |
| K210482 | Medline UNITE REFLEX Nitinol Staple System | Medline Industries, Inc. | 2021-04-22 | 62 | 0 |
| K210456 | Ligament Staple | Medacta International S.A. | 2021-04-12 | 55 | 0 |
| K203180 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2020-12-16 | 51 | 0 |
| K193305 | DynaClip Bone Staple | MedShape, Inc. | 2020-04-23 | 146 | 0 |
| K192447 | Superelastic Staple | Neosteo | 2020-02-28 | 175 | 0 |
| K191463 | DePuy Synthes Hammertoe Continuous Compression Implant | Synthes (USA) Products, LLC | 2020-02-26 | 268 | 2 |
| K191636 | APTUS Foot System | Medartis AG | 2019-08-16 | 58 | 0 |
| K190722 | TriMAX Implant System | Crossroads Extemity Systems, LLC | 2019-08-16 | 149 | 0 |
| K190166 | TriMed Nitinol Staple System | TriMed, Inc. | 2019-07-01 | 151 | 0 |
| K182943 | VERTEX Nitinol Staple System | Nvision Biomedical Technologies, LLC | 2019-04-04 | 163 | 0 |
| K182212 | Geo Staple System | Gramercy Extremity Orthopedics, LLC | 2019-01-11 | 149 | 0 |
| K181781 | DynaClipTM Bone Staple | MedShape, Inc. | 2018-11-05 | 125 | 0 |
| K181815 | DynaBridge | Fusion Orthopedics, LLC | 2018-10-15 | 98 | 0 |
| K181866 | MotoCLIP/HiMAX Step Staple Implant System | Crossroads Extremity Systems, LLC | 2018-08-09 | 28 | 0 |
| K180544 | DePuy Synthes Static Staples | Synthes (USA) Products, LLC | 2018-07-24 | 145 | 0 |
| K181410 | MotoCLIP/HiMAX Implant System | Crossroads Extremity Systems, LLC | 2018-06-29 | 30 | 0 |
| K173775 | Clench Compression Staple | F & A Foundation, LLC D.B.A. Reign Medical | 2018-04-06 | 115 | 0 |
| K173693 | Orbitum Bone Staple Implant, X and VI | Orthovestments, LLC | 2018-02-23 | 84 | 0 |
| K172205 | ExoToe Staple | Exotoe, LLC | 2018-01-11 | 174 | 0 |
| K172052 | Arthrex DynaNite Nitinol Staple | Arthrex, Inc. | 2017-12-13 | 160 | 0 |
| K172405 | SNIPER STAPLE SYSTEM, NON-STERILE | Trilliant Surgical | 2017-12-11 | 124 | 0 |
| K171473 | Compressyn™ Staple | Dallen Medical, Inc. | 2017-11-07 | 172 | 0 |
| K170923 | JAWS(TM) Nitinol Staple System | Paragon 28 | 2017-07-24 | 117 | 0 |
| K163226 | EPIC Extremely Small Staple | Epic Extremely, LLC | 2017-05-16 | 180 | 0 |
| K162354 | Sniper Staple System | Trilliant Surgical, Ltd. | 2017-04-20 | 240 | 0 |
| K162321 | EasyClip Xpress | Restore Surgical, LLC Dba Instratek | 2017-02-10 | 175 | 0 |
| K163440 | Stealth Staple System | First Ray, LLC | 2017-02-01 | 55 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda