510(k) Report

Devices descending from K082320

302 later devices reach Darco Small Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203228DART-FIRE EDGE Cannulated Screw SystemWright Medical20210—
+1K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc20210—
+1K190970PROSTEP™ TBI™ (Tailors Bunion Implant) SystemWrightmedicaltechnologyinc20191—
+1K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+1K170889HV Screw SystemWrightmedicaltechnologyinc20170—
+1K162353MICATM Screw SystemWrightmedicaltechnologyinc201733—
+1K153333Epic Extremity Cannulated Screw SystemEpic Extremity, LLC20161—
+1K143460Cannulated Screw SystemWrightmedicaltechnologyinc201511—
+1K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201579—
+1K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+1K142658Biomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp2014362
+1K133842Tyber Medical Trauma ScrewTyber Medical, LLC201423—
+1K132893Edge Orthopaedics Bite Compression ScrewIcon Orthopaedic Concepts Dba Edge Orthopaedics20130—
+1K130319Medline Cannulated ScrewMedline Industries, Inc.201312—
+1K121713PMT Bone ScrewsProvidence Medical Technology, Inc.201211
+1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+1K112772Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc201168—
+1K102429Ortholoc 3DI Ankle Plating System, Ortholoc Bone ScrewWrightmedicaltechnologyinc2010971
+2K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+2K253042Tyber Medical Trauma ScrewTyber Medical, LLC20260—
+2K241359Medline UNITE® MIS Foot Recon Screw SystemMedline Industries, LP20241—
+2K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+2K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+2K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+2K223392REVCON (TM) Screw SystemVoom Medical Devices, Inc.20230—
+2K221645PROstep (TM) MIS 5mm Chamfer Screw SystemWright Medical Technology20230—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+2K220723Hand Trauma Screw SystemSkeletal Dynamics, Inc.20221—
+2K220511Medline UNITE IM Fibula ImplantMedline Industries, LP20220—
+2K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+2K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+2K211612Medline UNITE REFLEX Dynamic DiscsMedline Industries, Inc.20211—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K211944Medline UNITE® Digital Fusion Screw SystemMedline Industries, Inc.20210—
+2K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+2K200062Foot and Ankle SystemLeith Medical, LLC20210—
+2K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+2K201319Medline UNITE Jones Fracture Screw SystemMedline Industires, Inc.20200—
+2K192974Tyber Medical Trauma ScrewTyber Medical, LLC20201—
+2K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+2K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+2K183620PROSTEP TBC Implant SystemWrightmedicaltechnologyinc20190—
+2K190586Monster® Screw SystemParagon 28, Inc.201921—
+2K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+2K190035Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc.20194—
+2K181377PROSTEP MICA Screw SystemWrightmedicaltechnologyinc20190—
+2K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+2K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+2K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+2K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K170782Medline UNITE® Snap-Off ScrewsMedline Industries, Inc.20170—
+2K170571Tyber Medical BioTy (TM) Nanotopography Trauma Screw, TyFix ScrewTyber Medical, LLC20170—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K170698ALLY (TM) Bone ScrewsProvidence Medical Technology, Inc.20170—
+2K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K163044ORTHOLOC® 3Di Ankle Fracture Plating SystemWrightmedicaltechnologyinc201713—
+2K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+2K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+2K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+2K153575Tyber Medical Trauma ScrewTyber Medical, LLC201612—
+2K153180Tyber Medical MST Trauma ScrewTyber Medical, LLC20152—
+2K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K131093Ortholoc (R) 3DI Ankle Plating SystemWrightmedicaltechnologyinc201326—
+2K121682Active Screw Bone ScrewIntelligent Implant Systems, LLC20120—
+2K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+2K120802Ortholoc (TM) 3DI Locking Screws Ortholoc (TM) Bone ScrewsWrightmedicaltechnologyinc201211—
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+3K254280F.A.S.T ScrewSteps Ortho20260—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+3K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+3K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+3K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K252901Tyber Medical Trauma ScrewTyber Medical, LLC20250—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+3K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+3K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+3K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+3K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+3K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K230908Hand Trauma Threaded Nail SystemSkeletal Dynamics, Inc.20230—
+3K230204ALPHALOK Plating SystemVilex, LLC20230—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+3K221558ALPHALOK Plating SystemVilex, LLC20222—
+3K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+3K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K213005Apollo Ankle Fracture Plating SystemGlw Medical, Inc.20221—
+3K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—