Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HWC — Predicate Candidate Screening
1,062 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
247 days90th percentile
1,062clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 | 245 | 0 |
| K262075 | Lapidus Screw Kit | Relja Innovations, LLC | 2026-07-22 | 30 | 0 |
| K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw Syst | Arthrex, Inc. | 2026-06-25 | 105 | 0 |
| K253108 | VEOFIX Snap Off Screw | Steps Ortho | 2026-06-05 | 254 | 0 |
| K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | 2026-05-30 | 52 | 0 |
| K261241 | TriMed Compression Screws | TriMed, Inc. | 2026-05-14 | 29 | 0 |
| K254215 | Arthrex Beaming System | Arthrex, Inc. | 2026-05-08 | 130 | 0 |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | 2026-05-01 | 134 | 0 |
| K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | 2026-04-17 | 28 | 0 |
| K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | 2026-04-10 | 226 | 0 |
| K253042 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2026-04-03 | 193 | 0 |
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; Dy | MedShape, Inc. | 2026-03-18 | 89 | 0 |
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2026-03-06 | 30 | 0 |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2025-12-31 | 111 | 0 |
| K251555 | Ultra™ Compression Screw System | Pace Surgical | 2025-11-06 | 169 | 0 |
| K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 | 2025-10-10 | 78 | 0 |
| K250536 | MetaFore Small Screw System | Extremity Medical, LLC | 2025-10-08 | 226 | 0 |
| K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025-10-02 | 34 | 0 |
| K252019 | CurvaFix Low Profile System | Curvafix, Inc. | 2025-08-29 | 60 | 0 |
| K251382 | Phoenix Sinus Tarsi Stent System | Astra Orthomed, Inc. | 2025-08-27 | 117 | 0 |
| K250867 | Dunamis Screw and Suture Locking System | Dunamis Medical, LLC | 2025-08-15 | 144 | 0 |
| K250251 | Eleganz Fusion Screw System (Fusion Screw System) | Dev4 | 2025-06-13 | 136 | 0 |
| K243943 | TriMed® Compression Screws | TriMed, Inc. | 2025-04-10 | 111 | 0 |
| K250613 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2025-04-02 | 33 | 0 |
| K250304 | TITANEX Screw Systems | Vilex, LLC | 2025-03-05 | 30 | 0 |
| K242896 | Caliber Intramedullary Fixation System | Nvision Biomedical Technologies | 2025-02-05 | 135 | 0 |
| K242442 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Sc | Innovate Orthopaedics, Ltd. | 2025-01-31 | 168 | 0 |
| K243195 | Arthrex SS VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2025-01-10 | 101 | 0 |
| K242348 | Locking Screw,CoCrMo | Double Medical Technology, Inc. | 2024-12-04 | 118 | 0 |
| K233567 | OsteoCoil™ Nitinol Compression System (Multiple Component PN | Flower Orthopedics Corporation Dba Conventus Flower Ortho | 2024-11-22 | 382 | 0 |
| K240175 | Tigon Medical Fractures, Instability, and Reconstruction (FI | Tigon Medical | 2024-10-29 | 280 | 0 |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2024-10-09 | 30 | 0 |
| K242671 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2024-10-04 | 28 | 0 |
| K241592 | Arthrex VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2024-08-31 | 89 | 0 |
| K241359 | Medline UNITE® MIS Foot Recon Screw System | Medline Industries, LP | 2024-08-02 | 80 | 0 |
| K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | 2024-07-03 | 58 | 0 |
| K240815 | Arthrex Cannulated Screw System | Arthrex, Inc. | 2024-06-13 | 80 | 0 |
| K233008 | Cannulated Headless Bone Screws | Aap Implantate AG | 2024-06-05 | 257 | 0 |
| K240530 | DynaNail Mini Tapered Hybrid | MedShape, Inc. | 2024-03-21 | 27 | 0 |
| K233912 | ARIX Cannulated Screw System | Jeil Medical Corporation | 2024-03-11 | 90 | 0 |
| K233198 | OSSIOfiber® Threaded Trimmable Fixation Nails | OSSIO , Ltd. | 2024-03-08 | 162 | 0 |
| K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2024-02-16 | 274 | 0 |
| K234040 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2024-01-18 | 28 | 2 |
| K231860 | TDM Screw System | Tdm Co., Ltd. | 2024-01-18 | 209 | 0 |
| K230507 | Zimed Distal Medial Tibial Plate and Screw System | Zimed Medikal | 2024-01-04 | 314 | 0 |
| K233396 | Cannulated Screw System | Smith & Nephew, Inc. | 2023-12-21 | 79 | 0 |
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K- | Medartis AG | 2023-11-03 | 98 | 0 |
| K231231 | MR Safety and Compatibility Testing and Labeling for Paragon | Paragon 28, Inc. | 2023-10-12 | 167 | 0 |
| K231649 | Intraosseous Fusion Device System | Auxano Medical, LLC | 2023-09-29 | 115 | 0 |
| K230946 | Accelerate Compression Screw System-Small Product Code ACC-S | Trax Surgical | 2023-09-15 | 164 | 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