Panels › Orthopedic › Product code HWC · Class 2
Screw, Fixation, Bone
Regulation 888.3040
22510(k)s in 12 months (1,070 all time)
7recalls in 12 months (389 all time)
359recalls that name a 510(k)
Top companies in HWC
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer, Inc. | 12 | 50 |
| Biomet, Inc. | 24 | 27 |
| Arthrex, Inc. | 47 | 1 |
| Acumed, LLC | 5 | 35 |
| Depuy Mitek, A Johnson & Johnson Co. | 13 | 21 |
| Synthes (Usa) | 31 | 3 |
| Smith & Nephew, Inc. | 27 | 6 |
| Smith & Nephew Inc., Endoscopy Division | 1 | 30 |
| Wrightmedicaltechnologyinc | 31 | 0 |
| Stryker Howmedica Osteonics Corp. | 0 | 30 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 20, 2020 | K193366 | T2 ICF Stryker GmbH | HWC |
| Mar 19, 2020 | K193491 | restor3d Metallic Interference Screw Restor3D | HWC |
| Feb 27, 2020 | K192096 | Omnia Medical Trauma Screws Omnia Medical, LLC | HWC |
| Feb 24, 2020 | K193451 | Titanium Interference Screws Biomet, Inc. | HWC |
| Feb 10, 2020 | K193156 | Arthrex Mini Comprehensive Fixation System - 1.0mm Screws Arthrex, Inc. | HWC |
| Jan 9, 2020 | K192975 | Tyber Medical Trauma Screws Tyber Medical, LLC | HWC |
| Jan 8, 2020 | K192974 | Tyber Medical Trauma Screw Tyber Medical, LLC | HWC |
| Dec 31, 2019 | K192578 | InCore TMT System Nextremity Solutions, Inc. | HWC |
| Nov 26, 2019 | K192745 | DePuy Synthes Trauma Screws Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | HWC |
| Nov 26, 2019 | K192417 | ARIX Cannulated Screw System Jeil Medical Corporation, KR | HWC |
| Nov 6, 2019 | K191651 | Arthrex Nano SwiveLock Suture Anchor Arthrex, Inc. | HWC |
| Oct 30, 2019 | K190921 | Arthrex Low Profile Screws Arthrex, Inc. | HWC |
| Oct 16, 2019 | K191771 | SECURE Screw A.M. Surgical, Inc. | HWC |
| Sep 13, 2019 | K190830 | TDM Screw Systems Tdm Co., Ltd., KR | HWC |
| Aug 28, 2019 | K191424 | Interphalangeal Joint Fusion Device Range Neosteo, FR | HWC |
| Aug 19, 2019 | K191342 | CrossRoads Screw System Crossroads Extemity Systems, LLC | HWC |
| Aug 13, 2019 | K190970 | PROSTEP TBI (Tailors Bunion Implant) System Wrightmedicaltechnologyinc | HWC |
| Jul 29, 2019 | K191289 | Bone Screw Line Addition Vilex IN Tennessee, Inc. | HWC |
| Jul 26, 2019 | K191817 | ActivOrtho Continuous Compression Screw System Activortho, Inc. | HWC |
| Jul 5, 2019 | K190324 | OrthoPediatrics Cannulated Screw System OrthoPediatrics Corp. | HWC |
| Jun 13, 2019 | K183363 | Treace Medical Concepts (TMC) Snap-Off Screw System Treace Medical Concepts, Inc. | HWC |
| Jun 10, 2019 | K183104 | Mini Cannulated Headed and Headless Screw Set Stryker GmbH | HWC |
| May 24, 2019 | K190231 | InCore® Lapidus Sterile Kits Nextremity Solutions, Inc. | HWC |
| May 21, 2019 | K182342 | IntraLock Lapidus System Fusion Orthopedics, LLC | HWC |
| Apr 17, 2019 | K183395 | Arthrex 2.5 mm Tenodesis Screw Arthrex, Inc. | HWC |
| Apr 3, 2019 | K190586 | Monster® Screw System Paragon 28, Inc. | HWC |
| Mar 26, 2019 | K183628 | Arthrex TensionLoc System Arthrex, Inc. | HWC |
| Mar 22, 2019 | K190430 | OsteoCentric Bone Plate and Screw System Osteocentric Trauma | HWC |
| Mar 13, 2019 | K183026 | Wright Jones Fracture System Wrightmedicaltechnologyinc | HWC |
| Mar 12, 2019 | K183603 | INnate Cannulated Screw System Exsomed Corporation | HWC |
| Mar 12, 2019 | K181610 | ActivOrtho Nitinol Compression Screw System Activortho, Inc. | HWC |
| Mar 1, 2019 | K180050 | CurvaFix Intramedullary Rodscrew System Curvafix, Inc. | HWC |
| Feb 19, 2019 | K183055 | Vector Hammertoe Correction System Nvision Biomedical Technologies, LLC | HWC |
| Feb 14, 2019 | K182677 | DynaNail Mini MedShape, Inc. | HWC |
| Feb 7, 2019 | K190035 | Biomet Headless Compression and Twist-Off Screws Biomet, Inc. | HWC |
| Jan 22, 2019 | K182955 | EZStart Interference Screw Conmed Corporation | HWC |
| Jan 11, 2019 | K181377 | PROSTEP MICA Screw System Wrightmedicaltechnologyinc | HWC |
| Dec 18, 2018 | K182989 | AURORA Screw System MiRus, LLC | HWC |
| Dec 18, 2018 | K182361 | Arthrex Compression FT Screws Arthrex, Inc. | HWC |
| Dec 7, 2018 | K180670 | ICONN Campbell Interference Screw Iconn Orthopedics, LLC | HWC |
| Dec 4, 2018 | K182949 | Healix Compression Screw System Nvision Biomedical Technologies, LLC | HWC |
| Nov 23, 2018 | K182684 | HammerTechTM Fixation System Fusion Orthopedics, LLC | HWC |
| Nov 23, 2018 | K180573 | Responsive Arthroscopy Interference Screw System Responsive Arthroscopy, LLC | HWC |
| Nov 21, 2018 | K180541 | DePuy Synthes 2.0 mm Quick Insertion Screws Synthes USA Products, LLC | HWC |
| Oct 26, 2018 | K181898 | Two-Step Implant System Trilliant Surgical | HWC |
| Sep 7, 2018 | K182148 | SILVERBACK Gorilla Plating System Paragon 28, Inc. | HWC |
| Jul 17, 2018 | K180348 | Field Orthopaedics Micro Screw System Field Orthopaedics Pty, Ltd., AU | HWC |
| Jul 13, 2018 | K173556 | Injection Screw Biedermann Medtech, Inc. | HWC |
| Jul 11, 2018 | K180024 | SALVATION Midfoot Nail Wrightmedicaltechnologyinc | HWC |
| Jun 20, 2018 | K180377 | Fracture and Correction System In2bones USA, LLC | HWC |
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