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 2 of 11
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K213199 | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System | Stryker GmbH | 2022-01-11 | Traditional | PDF ↗ |
| K203595 | DynaFuse Fixation System | MedShape, Inc. | 2022-01-04 | Traditional | PDF ↗ |
| K212547 | Quick-Start Screws | Innovate Orthopaedics Limited | 2021-12-30 | Traditional | PDF ↗ |
| K211770 | R3ACT Stabilization System | Paragon 28, Inc. | 2021-12-25 | Traditional | PDF ↗ |
| K213301 | InCore Subtalar System | Nextremity Solutions, Inc. | 2021-12-21 | Traditional | PDF ↗ |
| K213596 | OSSIOfiber Compression Screw, 3.5mm | OSSIO , Ltd. | 2021-12-21 | Traditional | PDF ↗ |
| K213530 | Nextra CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2021-12-09 | Special | PDF ↗ |
| K213421 | Vector® Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2021-11-19 | Special | PDF ↗ |
| K212996 | Sterile PHALINX Hammertoe System | Wrightmedicaltechnologyinc | 2021-11-16 | Traditional | PDF ↗ |
| K202326 | BESPA Charcot System | Bespa Global, LLC | 2021-11-09 | Traditional | PDF ↗ |
| K213036 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2021-10-21 | Special | PDF ↗ |
| K210490 | ChM 4.5mm Cortical screws | Chm Sp. Z O.O. | 2021-10-05 | Traditional | PDF ↗ |
| K211996 | Nexta PEEK Hammertoe Correction System | Nextremity Solutions, Inc. | 2021-09-23 | Traditional | PDF ↗ |
| K210792 | Auxein Nailing System | Auxein Medical Private Limited | 2021-08-25 | Special | PDF ↗ |
| K203029 | Auxilock Titanium Interference Screw | Auxein Medical Private Limited | 2021-08-20 | Traditional | PDF ↗ |
| K211783 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | 2021-08-06 | Traditional | PDF ↗ |
| K211435 | PAO Cortical Screw | Medacta International S.A. | 2021-08-06 | Traditional | PDF ↗ |
| K211290 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021-08-03 | Special | PDF ↗ |
| K210159 | IntraLock System | Fusion Orthopedics, LLC | 2021-07-23 | Traditional | PDF ↗ |
| K211944 | Medline UNITE® Digital Fusion Screw System | Medline Industries, Inc. | 2021-07-22 | Special | PDF ↗ |
| K210994 | Arthrex Beveled FT Screws | Arthrex, Inc. | 2021-06-01 | Traditional | PDF ↗ |
| K211261 | Axis Charcot Fixation System | Extremity Medical, LLC | 2021-05-28 | Special | PDF ↗ |
| K203228 | DART-FIRE EDGE Cannulated Screw System | Wright Medical | 2021-05-11 | Traditional | PDF ↗ |
| K210754 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | 2021-04-14 | Special | PDF ↗ |
| K210268 | LTJ Screws and Washer | Azurmeds, Inc. | 2021-02-26 | Special | PDF ↗ |
| K203381 | Dynanail Mini Hybrid | MedShape, Inc. | 2021-01-15 | Traditional | PDF ↗ |
| K203105 | Inion CompressOn Screw | Inion OY | 2021-01-13 | Traditional | PDF ↗ |
| K193497 | Fixone Biocomposite Interference Screw | Aju Pharm Co., Ltd. | 2021-01-05 | Traditional | PDF ↗ |
| K203239 | Arthrex Low Profile Screws | Arthrex, Inc. | 2020-12-30 | Traditional | PDF ↗ |
| K203467 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | 2020-12-23 | Special | PDF ↗ |
| K200291 | CREED Cannulated Screws | Glw Medical, Inc. | 2020-12-16 | Traditional | PDF ↗ |
| K203011 | Monster Screw System | Paragon 28, Inc. | 2020-11-13 | Special | PDF ↗ |
| K202589 | APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System | Medartis AG | 2020-11-06 | Traditional | PDF ↗ |
| K202817 | GEO Bone Screw System | Gramercy Extremity Orthopedics, LLC | 2020-10-22 | Special | PDF ↗ |
| K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw System | Osteomed, LLC | 2020-10-15 | Special | PDF ↗ |
| K202569 | Responsive Arthroscopy Interference Screw System | Responsive Arthroscopy, LLC | 2020-09-23 | Special | PDF ↗ |
| K200987 | LTJ Screws and Washer | Azurmeds, Inc. | 2020-09-22 | Traditional | PDF ↗ |
| K201850 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2020-08-04 | Special | PDF ↗ |
| K193660 | OSSIOfiber Compression Screws | OSSIO , Ltd. | 2020-07-30 | Traditional | PDF ↗ |
| K201662 | REDUCT® Headless Compression Screw System | Skeletal Dynamics, Inc. | 2020-07-16 | Special | PDF ↗ |
| K201556 | Intraosseous Fixation System | Extremity Medical, LLC | 2020-07-08 | Special | PDF ↗ |
| K200840 | DuoHex CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2020-06-26 | Traditional | PDF ↗ |
| K200226 | RetroFix | Retrofix Screws, LLC | 2020-06-26 | Traditional | PDF ↗ |
| K201430 | InFrame Cannulated Fixation System | Exsomed Corp. | 2020-06-20 | Special | PDF ↗ |
| K201319 | Medline UNITE Jones Fracture Screw System | Medline Industires, Inc. | 2020-06-17 | Special | PDF ↗ |
| K200124 | InCore MPJ System | Nextremity Solutions, Inc. | 2020-05-13 | Traditional | PDF ↗ |
| K200914 | Healix Compression Screw System | Nvision Biomedical Technologies, Inc. | 2020-05-05 | Special | PDF ↗ |
| K200259 | Headless Compression Screw System | Osteocentric Extremities, LLC | 2020-05-04 | Special | PDF ↗ |
| K191995 | S4 Screw System | Subchondral Solutions, Inc. | 2020-04-18 | Traditional | PDF ↗ |
| K193366 | T2 ICF | Stryker GmbH | 2020-03-20 | Traditional | PDF ↗ |
| K193491 | restor3d Metallic Interference Screw | Restor3D | 2020-03-19 | Traditional | PDF ↗ |
| K192096 | Omnia Medical Trauma Screws | Omnia Medical, LLC | 2020-02-27 | Traditional | PDF ↗ |
| K193451 | Titanium Interference Screws | Biomet, Inc. | 2020-02-24 | Traditional | PDF ↗ |
| K193156 | Arthrex Mini Comprehensive Fixation System - 1.0mm Screws | Arthrex, Inc. | 2020-02-10 | Traditional | PDF ↗ |
| K192975 | Tyber Medical Trauma Screws | Tyber Medical, LLC | 2020-01-09 | Traditional | PDF ↗ |
| K192974 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2020-01-08 | Traditional | PDF ↗ |
| K192578 | InCore TMT System | Nextremity Solutions, Inc. | 2019-12-31 | Traditional | PDF ↗ |
| K192745 | DePuy Synthes Trauma Screws | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2019-11-26 | Traditional | PDF ↗ |
| K192417 | ARIX Cannulated Screw System | Jeil Medical Corporation | 2019-11-26 | Traditional | PDF ↗ |
| K191651 | Arthrex Nano SwiveLock Suture Anchor | Arthrex, Inc. | 2019-11-06 | Traditional | PDF ↗ |
| K190921 | Arthrex Low Profile Screws | Arthrex, Inc. | 2019-10-30 | Traditional | PDF ↗ |
| K191771 | SECURE Screw | A.M. Surgical, Inc. | 2019-10-16 | Traditional | PDF ↗ |
| K190830 | TDM Screw Systems | Tdm Co., Ltd. | 2019-09-13 | Traditional | PDF ↗ |
| K191424 | Interphalangeal Joint Fusion Device Range | Neosteo | 2019-08-28 | Traditional | PDF ↗ |
| K191342 | CrossRoads Screw System | Crossroads Extemity Systems, LLC | 2019-08-19 | Special | PDF ↗ |
| K190970 | PROSTEP TBI (Tailors Bunion Implant) System | Wrightmedicaltechnologyinc | 2019-08-13 | Traditional | PDF ↗ |
| K191289 | Bone Screw Line Addition | Vilex IN Tennessee, Inc. | 2019-07-29 | Traditional | PDF ↗ |
| K191817 | ActivOrtho Continuous Compression Screw System | Activortho, Inc. | 2019-07-26 | Traditional | PDF ↗ |
| K190324 | OrthoPediatrics Cannulated Screw System | OrthoPediatrics Corp. | 2019-07-05 | Traditional | PDF ↗ |
| K183363 | Treace Medical Concepts (TMC) Snap-Off Screw System | Treace Medical Concepts, Inc. | 2019-06-13 | Traditional | PDF ↗ |
| K183104 | Mini Cannulated Headed and Headless Screw Set | Stryker GmbH | 2019-06-10 | Traditional | PDF ↗ |
| K190231 | InCore® Lapidus Sterile Kits | Nextremity Solutions, Inc. | 2019-05-24 | Traditional | PDF ↗ |
| K182342 | IntraLock Lapidus System | Fusion Orthopedics, LLC | 2019-05-21 | Traditional | PDF ↗ |
| K183395 | Arthrex 2.5 mm Tenodesis Screw | Arthrex, Inc. | 2019-04-17 | Traditional | PDF ↗ |
| K190586 | Monster® Screw System | Paragon 28, Inc. | 2019-04-03 | Special | PDF ↗ |
| K183628 | Arthrex TensionLoc System | Arthrex, Inc. | 2019-03-26 | Traditional | PDF ↗ |
| K190430 | OsteoCentric Bone Plate and Screw System | Osteocentric Trauma | 2019-03-22 | Special | PDF ↗ |
| K183026 | Wright Jones Fracture System | Wrightmedicaltechnologyinc | 2019-03-13 | Traditional | PDF ↗ |
| K181610 | ActivOrtho Nitinol Compression Screw System | Activortho, Inc. | 2019-03-12 | Traditional | PDF ↗ |
| K183603 | INnate Cannulated Screw System | Exsomed Corporation | 2019-03-12 | Special | PDF ↗ |
| K180050 | CurvaFix Intramedullary Rodscrew System | Curvafix, Inc. | 2019-03-01 | Traditional | PDF ↗ |
| K183055 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, LLC | 2019-02-19 | Traditional | PDF ↗ |
| K182677 | DynaNail Mini | MedShape, Inc. | 2019-02-14 | Traditional | PDF ↗ |
| K190035 | Biomet Headless Compression and Twist-Off Screws | Biomet, Inc. | 2019-02-07 | Special | PDF ↗ |
| K182955 | EZStart Interference Screw | Conmed Corporation | 2019-01-22 | Traditional | PDF ↗ |
| K181377 | PROSTEP MICA Screw System | Wrightmedicaltechnologyinc | 2019-01-11 | Special | PDF ↗ |
| K182989 | AURORA Screw System | MiRus, LLC | 2018-12-18 | Traditional | PDF ↗ |
| K182361 | Arthrex Compression FT Screws | Arthrex, Inc. | 2018-12-18 | Traditional | PDF ↗ |
| K180670 | ICONN Campbell Interference Screw | Iconn Orthopedics, LLC | 2018-12-07 | Traditional | PDF ↗ |
| K182949 | Healix Compression Screw System | Nvision Biomedical Technologies, LLC | 2018-12-04 | Traditional | PDF ↗ |
| K182684 | HammerTechTM Fixation System | Fusion Orthopedics, LLC | 2018-11-23 | Traditional | PDF ↗ |
| K180573 | Responsive Arthroscopy Interference Screw System | Responsive Arthroscopy, LLC | 2018-11-23 | Traditional | PDF ↗ |
| K180541 | DePuy Synthes 2.0 mm Quick Insertion Screws | Synthes USA Products, LLC | 2018-11-21 | Traditional | PDF ↗ |
| K181898 | Two-Step Implant System | Trilliant Surgical | 2018-10-26 | Traditional | PDF ↗ |
| K182148 | SILVERBACK Gorilla Plating System | Paragon 28, Inc. | 2018-09-07 | Special | PDF ↗ |
| K180348 | Field Orthopaedics Micro Screw System | Field Orthopaedics Pty, Ltd. | 2018-07-17 | Traditional | PDF ↗ |
| K173556 | Injection Screw | Biedermann Medtech, Inc. | 2018-07-13 | Traditional | PDF ↗ |
| K180024 | SALVATION Midfoot Nail | Wrightmedicaltechnologyinc | 2018-07-11 | Traditional | PDF ↗ |
| K180377 | Fracture and Correction System | In2bones USA, LLC | 2018-06-20 | Traditional | PDF ↗ |
| K180500 | VariAx 2 System | Stryker GmbH | 2018-06-04 | Traditional | PDF ↗ |
Product code HWC · Class II · Orthopedic. Data: openFDA.