FDA Product Code
FDA Product Code HWC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3040
510(k) Clearances — 1,069 records · page 1 of 11
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K263116 | OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts | OsteoCentric Technologies | 2026-10-02 | Special | PDF ↗ |
| K262975 | Arthrex Beaming System | Arthrex, Inc. | 2026-09-25 | Special | PDF ↗ |
| K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | 2026-09-23 | Traditional | PDF ↗ |
| K254280 | F.A.S.T Screw | Steps Ortho | 2026-09-21 | Traditional | PDF ↗ |
| K261057 | ActivaScrew Cannulated COM | Bioretec, Ltd. | 2026-09-04 | Traditional | PDF ↗ |
| K260106 | OsteoCoil GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | 2026-08-24 | Traditional | PDF ↗ |
| K262344 | Large Compression Screws | TriMed, Inc. | 2026-08-12 | Special | PDF ↗ |
| K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 | Special | PDF ↗ |
| K262075 | Lapidus Screw Kit | Relja Innovations, LLC | 2026-07-22 | Special | PDF ↗ |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. | 2026-06-25 | Traditional | PDF ↗ |
| K253108 | VEOFIX Snap Off Screw | Steps Ortho | 2026-06-05 | Traditional | PDF ↗ |
| K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | 2026-05-30 | Special | PDF ↗ |
| K261241 | TriMed Compression Screws | TriMed, Inc. | 2026-05-14 | Special | PDF ↗ |
| K254215 | Arthrex Beaming System | Arthrex, Inc. | 2026-05-08 | Traditional | PDF ↗ |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | 2026-05-01 | Traditional | PDF ↗ |
| K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | 2026-04-17 | Special | PDF ↗ |
| K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | 2026-04-10 | Traditional | PDF ↗ |
| K253042 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2026-04-03 | Traditional | PDF ↗ |
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | MedShape, Inc. | 2026-03-18 | Traditional | PDF ↗ |
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2026-03-06 | Special | PDF ↗ |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2025-12-31 | Traditional | PDF ↗ |
| K251555 | Ultra Compression Screw System | Pace Surgical | 2025-11-06 | Traditional | PDF ↗ |
| K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 | 2025-10-10 | Traditional | PDF ↗ |
| K250536 | MetaFore Small Screw System | Extremity Medical, LLC | 2025-10-08 | Traditional | PDF ↗ |
| K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025-10-02 | Special | PDF ↗ |
| K252019 | CurvaFix Low Profile System | Curvafix, Inc. | 2025-08-29 | Traditional | PDF ↗ |
| K251382 | Phoenix Sinus Tarsi Stent System | Astra Orthomed, Inc. | 2025-08-27 | Traditional | PDF ↗ |
| K250867 | Dunamis Screw and Suture Locking System | Dunamis Medical, LLC | 2025-08-15 | Traditional | PDF ↗ |
| K250251 | Eleganz Fusion Screw System (Fusion Screw System) | Dev4 | 2025-06-13 | Traditional | PDF ↗ |
| K243943 | TriMed® Compression Screws | TriMed, Inc. | 2025-04-10 | Traditional | PDF ↗ |
| K250613 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2025-04-02 | Special | PDF ↗ |
| K250304 | TITANEX Screw Systems | Vilex, LLC | 2025-03-05 | Special | PDF ↗ |
| K242896 | Caliber Intramedullary Fixation System | Nvision Biomedical Technologies | 2025-02-05 | Traditional | PDF ↗ |
| K242442 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics, Ltd. | 2025-01-31 | Traditional | PDF ↗ |
| K243195 | Arthrex SS VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. | 2025-01-10 | Traditional | PDF ↗ |
| K242348 | Locking Screw,CoCrMo | Double Medical Technology, Inc. | 2024-12-04 | Abbreviated | PDF ↗ |
| K233567 | OsteoCoil Nitinol Compression System (Multiple Component PNs) | Flower Orthopedics Corporation Dba Conventus Flower Ortho | 2024-11-22 | Traditional | PDF ↗ |
| K240175 | Tigon Medical Fractures, Instability, and Reconstruction (FIRE) | Tigon Medical | 2024-10-29 | Traditional | PDF ↗ |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2024-10-09 | Special | PDF ↗ |
| K242671 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2024-10-04 | Special | PDF ↗ |
| K241592 | Arthrex VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. | 2024-08-31 | Traditional | PDF ↗ |
| K241359 | Medline UNITE® MIS Foot Recon Screw System | Medline Industries, LP | 2024-08-02 | Traditional | PDF ↗ |
| K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | 2024-07-03 | Traditional | PDF ↗ |
| K240815 | Arthrex Cannulated Screw System | Arthrex, Inc. | 2024-06-13 | Traditional | PDF ↗ |
| K233008 | Cannulated Headless Bone Screws | Aap Implantate AG | 2024-06-05 | Traditional | PDF ↗ |
| K240530 | DynaNail Mini Tapered Hybrid | MedShape, Inc. | 2024-03-21 | Special | PDF ↗ |
| K233912 | ARIX Cannulated Screw System | Jeil Medical Corporation | 2024-03-11 | Traditional | PDF ↗ |
| K233198 | OSSIOfiber® Threaded Trimmable Fixation Nails | OSSIO , Ltd. | 2024-03-08 | Traditional | PDF ↗ |
| K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2024-02-16 | Traditional | PDF ↗ |
| K234040 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2024-01-18 | Special | PDF ↗ |
| K231860 | TDM Screw System | Tdm Co., Ltd. | 2024-01-18 | Special | PDF ↗ |
| K230507 | Zimed Distal Medial Tibial Plate and Screw System | Zimed Medikal | 2024-01-04 | Traditional | PDF ↗ |
| K233396 | Cannulated Screw System | Smith & Nephew, Inc. | 2023-12-21 | Traditional | PDF ↗ |
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension | Medartis AG | 2023-11-03 | Traditional | PDF ↗ |
| K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices | Paragon 28, Inc. | 2023-10-12 | Traditional | PDF ↗ |
| K231649 | Intraosseous Fusion Device System | Auxano Medical, LLC | 2023-09-29 | Traditional | PDF ↗ |
| K230946 | Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L | Trax Surgical | 2023-09-15 | Traditional | PDF ↗ |
| K231504 | TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System | Vilex, LLC | 2023-09-11 | Traditional | PDF ↗ |
| K231819 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics Limited | 2023-09-05 | Traditional | PDF ↗ |
| K223468 | Nexis® compressive screws | Novastep | 2023-08-30 | Abbreviated | PDF ↗ |
| K231236 | IBS-B MIS Beveled Screw System | In2bones USA, LLC | 2023-07-27 | Traditional | PDF ↗ |
| K230945 | Forma Medical Headless Compression Screw | Forma Medical, Inc. | 2023-07-18 | Traditional | PDF ↗ |
| K230595 | OsteoCentric ACL Fixation System | OsteoCentric Technologies | 2023-06-29 | Traditional | PDF ↗ |
| K230867 | Bone Bolt System | University of Utah, Department of Orthopaedics | 2023-06-26 | Traditional | PDF ↗ |
| K230397 | Cut Screw - Percutaneous Compression Screw | GM Dos Reis Industria e Comercio Ltda. | 2023-06-12 | Traditional | PDF ↗ |
| K230744 | Acumed Acutrak 3 Headless Compression Screw System | Acumed, LLC | 2023-06-09 | Traditional | PDF ↗ |
| K230908 | Hand Trauma Threaded Nail System | Skeletal Dynamics, Inc. | 2023-04-28 | Special | PDF ↗ |
| K230053 | SimpliFix Hip System | Stabiliz Orthopaedics, Inc. | 2023-04-19 | Traditional | PDF ↗ |
| K230749 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2023-04-17 | Special | PDF ↗ |
| K223392 | REVCON (TM) Screw System | Voom Medical Devices, Inc. | 2023-02-28 | Traditional | PDF ↗ |
| K221645 | PROstep(TM) MIS 5mm Chamfer Screw System | Wright Medical Technology | 2023-02-17 | Abbreviated | PDF ↗ |
| K230118 | Bony Trauma Extremity System (BTES) Screw Range, NX Nail | Field Orthopaedics Pty, Ltd. | 2023-02-16 | Special | PDF ↗ |
| K223761 | OIC Intramedullary Screw System | Orthopaedic Implant Company | 2023-02-13 | Traditional | PDF ↗ |
| K223847 | CREED Cannulated Screws | Glw, Inc. | 2023-01-25 | Special | PDF ↗ |
| K221090 | Metal Cannulated Screw | Double Medical Technology, Inc. | 2023-01-10 | Traditional | PDF ↗ |
| K222799 | Haymaker® Screw System | Orthocircle Spine D.B.A. OC Medical Devices | 2023-01-10 | Traditional | PDF ↗ |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional | Acumed, LLC | 2022-12-29 | Traditional | PDF ↗ |
| K221193 | OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm | OSSIO , Ltd. | 2022-12-23 | Traditional | PDF ↗ |
| K222820 | BRM TOOL Screws, BIOPLAN Subtalar Implant | Brm Extremities | 2022-12-16 | Traditional | PDF ↗ |
| K223184 | Phantom Metatarsal Shortening System | Paragon 28, Inc. | 2022-12-16 | Traditional | PDF ↗ |
| K221342 | REDEMPTION Beaming System | Vilex, LLC | 2022-12-13 | Traditional | PDF ↗ |
| K220921 | Metal Bone Screw | Double Medical Technology, Inc. | 2022-12-12 | Traditional | PDF ↗ |
| K222967 | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws | Avanti Orthopaedics, Inc. | 2022-11-23 | Traditional | PDF ↗ |
| K222564 | Treace Medical Concepts (TMC) Hammertoe Fixation System | Treace Medical Concepts, Inc. | 2022-11-15 | Traditional | PDF ↗ |
| K221610 | Nextra CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2022-11-04 | Traditional | PDF ↗ |
| K222505 | CurvaFix IM System | Curvafix, Inc. | 2022-10-27 | Traditional | PDF ↗ |
| K220359 | Tandry Compression Screw System | Microware Precision Co., Ltd. | 2022-09-20 | Traditional | PDF ↗ |
| K220839 | Arthrex Compression FT Pins | Arthrex, Inc. | 2022-09-19 | Traditional | PDF ↗ |
| K222409 | CAPTIVATE® Compression Screws | Globus Medical, Inc. | 2022-09-08 | Special | PDF ↗ |
| K213614 | Cannulated Screws | Maxxion Medical, LLC | 2022-08-03 | Traditional | PDF ↗ |
| K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System | Stryker GmbH | 2022-06-10 | Traditional | PDF ↗ |
| K220723 | Hand Trauma Screw System | Skeletal Dynamics, Inc. | 2022-05-12 | Traditional | PDF ↗ |
| K220892 | ExsoMed INnate NanoTM Lag Screw System | Exsomed Corp. | 2022-04-27 | Special | PDF ↗ |
| K210146 | Cannulated Compression Device System | Orthopedic Designs North America, Inc. | 2022-04-13 | Traditional | PDF ↗ |
| K220511 | Medline UNITE IM Fibula Implant | Medline Industries, LP | 2022-03-22 | Special | PDF ↗ |
| K212755 | SIGNUS SACRONAIL® Transsacral Stabilization System | Signus Medizintechnik GmbH | 2022-03-10 | Traditional | PDF ↗ |
| K203335 | MectaScrew Extension | Medacta International S.A. | 2022-02-03 | Traditional | PDF ↗ |
| K211628 | MIS Precision Chevron Bunion System | Relja Innovations, LLC | 2022-01-31 | Traditional | PDF ↗ |
| K213572 | JuniOrtho Plating System | Orthofix Srl | 2022-01-18 | Traditional | PDF ↗ |
| K203773 | BRM TOOL Screws | Brm Extremities Srl | 2022-01-14 | Traditional | PDF ↗ |
Product code HWC · Class II · Orthopedic. Data: openFDA.