510(k) Report

Devices descending from K963192

581 later devices reach Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+1K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+1K191817ActivOrtho Continuous Compression Screw SystemActivortho, Inc.20190—
+1K181610ActivOrtho Nitinol Compression Screw SystemActivortho, Inc.20191—
+1K170021SMV Scientific Cannulated ScrewsSmv Scientific20178—
+1K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+1K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+1K153622First Ray Internal Bone Staple SystemFirst Ray, LLC20164—
+1K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.201674
+1K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+1K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+1K143394Acumed Small Fragment Base SetAcumed, LLC201518—
+1K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+1K140891Biomet Cannulated Screw SystemBiomet, Inc.2014165
+1K132910Depuy Synthes Spine Dens Access SystemSynthes USA Products, LLC20134—
+1K130108Double Engine Bone Plate and Screw SystemsXiamen Double Engine Medical Material Co., Ltd.20139—
+1K112240Dyna Locking Cannulated ScrewU&I Corp.201214—
+1K1105923.7MM/5.0MM Dynamic Locking ScrewSynthes USA201102
+1K102343Emerge Medical Cannulated Screw Fixation SystemEmerge Medical2010220—
+1K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.200811—
+1K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+1K021233Aap Cannulated ScrewsAap Implantate AG2002181—
+1K013534Self-Countersinking Bone ScrewBiomet Orthopedics, Inc.2001241—
+2K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+2K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+2K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+2K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+2K242988Genostis Osteosynthesis SystemGenostis AF20250—
+2K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+2K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+2K240958Locking Plates and Screws SystemsHebei Ruihe Medical Devices Co., Ltd.20250—
+2K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+2K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+2K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+2K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K221088Anatomic Bone PlateDouble Medical Technology, Inc.20231—
+2K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+2K220921Metal Bone ScrewDouble Medical Technology, Inc.20221—
+2K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+2K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+2K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+2K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+2K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+2K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+2K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH20222—
+2K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+2K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+2K211435PAO Cortical ScrewMedacta International S.A.20210—
+2K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+2K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+2K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+2K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+2K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+2K200259Headless Compression Screw SystemOsteocentric Extremities, LLC20200—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+2K192744CORRIDOR Fixation SystemGlobus Medical, Inc.20192—
+2K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+2K190830TDM Screw SystemsTdm Co., Ltd.20191—
+2K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+2K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+2K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+2K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+2K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K163440Stealth Staple SystemFirst Ray, LLC20173—
+2K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+2K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.201613—
+2K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+2K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+2K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+2K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+2K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+2K142707AIS Odontoid Fracture Fixation SystemAesculap Implant System, Inc.20143—
+2K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+2K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+2K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+2K111316Aap Cannulated ScrewsAap Implantate AG201139—
+2K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+2K103705Low Profile ScrewsArthrex, Inc.2011219—
+2K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+2K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+2K080101Aap Cannulated Screw and Darco Headed ScrewAap Implantate AG2008180—
+2K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+2K024086Propeller Head Small Cannulated Screw SystemBiomet Orthopedics, Inc.2003171—
+2K022952Modular Head Bone ScrewBiomet, Inc.20020—
+3K262344Large Compression ScrewsTriMed, Inc.20260—
+3K261241TriMed Compression ScrewsTriMed, Inc.20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+3K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+3K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—