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 |
|---|---|---|---|
| Jun 4, 2018 | K180500 | VariAx 2 System Stryker GmbH | HWC |
| May 9, 2018 | K180932 | Diamond Orthopedic Bone Fixation Screws and Pins Diamond Orthopedic, LLC | HWC |
| Apr 25, 2018 | K180257 | InCore® Lapidus System Nextremity Solutions, Inc. | HWC |
| Apr 20, 2018 | K180753 | SafetyFix EasyOut System Safetyfix Medical Technologies, Inc. | HWC |
| Feb 12, 2018 | K173710 | MotoBAND CP Implant System Crossroads Extremity Systems, LLC | HWC |
| Feb 7, 2018 | K172698 | G-Beam Fusion Beaming System Orthofix Srl, IT | HWC |
| Jan 12, 2018 | K171628 | HBS2 Headless Bone Screw Stuckenbrock Medizintechnik GmbH, DE | HWC |
| Dec 22, 2017 | K172383 | Arthrosurface Bone Screws Arthrosurface, Inc. | HWC |
| Dec 14, 2017 | K173286 | Cannulated Screw Internal Fixation System Life Spine, Inc. | HWC |
| Nov 28, 2017 | K170688 | PITStop® implant In2bones Sas, FR | HWC |
| Nov 27, 2017 | K173135 | VariAx 2 System Stryker GmbH | HWC |
| Oct 25, 2017 | K172617 | Treace Medical Concepts (TMC) Compression Screw System Treace Medical Concepts, Inc. | HWC |
| Oct 23, 2017 | K172213 | MECRON Cannulated Screw System Merete GmbH, DE | HWC |
| Oct 23, 2017 | K170056 | IRENE Cannulated Screw System Tianjin Zhengtian Medical Instrument Co., Ltd., CN | HWC |
| Oct 2, 2017 | K172596 | Large Screws Range Newclip Technics, FR | HWC |
| Sep 14, 2017 | K163148 | BePOD® Foot Screws Fournitures Hospitalieres Industrie, FR | HWC |
| Sep 8, 2017 | K163710 | BePOD® EZ Weil Screws Fournitures Hospitalieres Industrie, FR | HWC |
| Sep 7, 2017 | K162171 | S4 Screw System Subchondral Solutions | HWC |
| Sep 1, 2017 | K171558 | ExsoMed ITN Cannulated Screw System Exsomed Holdings Company, LLC | HWC |
| Aug 18, 2017 | K171407 | ExsoMed ArcPhix and ExsoMed ArrowPhix Exsomed Holding Company, LLC | HWC |
| Aug 18, 2017 | K170782 | Medline UNITE® Snap-Off Screws Medline Industries, Inc. | HWC |
| Aug 11, 2017 | K170624 | TalarLift STS Fusion Orthopedics, LLC | HWC |
| Aug 7, 2017 | K170038 | FuzeFix Screw System Fusion Orthopedics, LLC | HWC |
| Jul 14, 2017 | K162153 | Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System Ascension Orthopedics | HWC |
| Jul 13, 2017 | K171018 | Axis Charcot Fixation System, 4.5 to 8.5mm Screw System Extremity Medical, LLC | HWC |
| Jul 7, 2017 | K171448 | Hammertoe Correction System Life Spine, Inc. | HWC |
| Jun 27, 2017 | K162874 | Cannulated Screws Neoortho Neoortho Produtos Ortopedicos S/A, BR | HWC |
| Jun 20, 2017 | K170571 | Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw Tyber Medical, LLC | HWC |
| Jun 9, 2017 | K162685 | 2-Piece Hammertoe Correction System Life Spine, Inc. | HWC |
| Jun 6, 2017 | K170687 | Flower Bone Screw Set Flower Orthopedics Corporation | HWC |
| May 31, 2017 | K170698 | ALLY(TM) Bone Screws Providence Medical Technology, Inc. | HWC |
| May 22, 2017 | K170021 | SMV Scientific Cannulated Screws Smv Scientific | HWC |
| May 11, 2017 | K170382 | Arthrex Compression Screws Arthrex, Inc. | HWC |
| May 10, 2017 | K170594 | I.B.S. osteosynthesis screws In2bones Sas, FR | HWC |
| May 1, 2017 | K162825 | CAPTIVATE Compression Screws Globus Medical, Inc. | HWC |
| Apr 26, 2017 | K170889 | HV Screw System Wrightmedicaltechnologyinc | HWC |
| Apr 24, 2017 | K170012 | Foot and Hand Motion Newclip Technics, FR | HWC |
| Apr 13, 2017 | K162353 | MICATM Screw System Wrightmedicaltechnologyinc | HWC |
| Apr 4, 2017 | K170040 | BePOD Cannulated Arthrodesis Screws Fournitures Hospitalieres Industrie, FR | HWC |
| Apr 4, 2017 | K163303 | OsteoMed ExtremiFix Mid and Large Screw System Osteomed, LLC | HWC |
| Mar 8, 2017 | K163489 | OrthoSolutions 'System26' Bone Screws Ortho Solutions UK Limited, GB | HWC |
| Mar 3, 2017 | K170350 | ToeMATE® Hammertoe Correction System Arthrosurface, Inc. | HWC |
| Feb 28, 2017 | K163038 | EPIC Extremity Snap-Off Screw Epic Extremity, LLC | HWC |
| Feb 21, 2017 | K161894 | SurgTech Trauma System Surgtech, Inc. | HWC |
| Feb 16, 2017 | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm C Synthes USA Products, LLC | HWC |
| Feb 9, 2017 | K161334 | RASL Repair Kit Radicle Orthopaedics, Inc. | HWC |
| Jan 18, 2017 | K161904 | GEO Bone Screw System Gramercy Extremity Orthopeidics, LLC | HWC |
| Dec 19, 2016 | K161259 | KLS Martin Cannulated Headless Screws KLS Martin L.P. | HWC |
| Dec 5, 2016 | K160946 | 4.0 and 6.5 Cancellous Bone Screw and Washer Smv Scientific | HWC |
| Nov 22, 2016 | K161778 | ToeTac 10° Hammertoe Fixation System Restore Surgical, LLC Dba Instratek | HWC |
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