510(k) Report

Devices descending from K962823

836 later devices reach Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+4K230546SignexOsteonic Co., Ltd.20242—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+4K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+4K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+4K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+4K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+4K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+4K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+4K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+4K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+4K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+4K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+4K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+4K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+4K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K212552Correx SoftwareVilex, LLC20210—
+4K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K211435PAO Cortical ScrewMedacta International S.A.20210—
+4K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+4K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+4K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+4K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+4K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+4K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+4K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+4K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+4K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K202307Activ FuseNewclip Technics20200—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+4K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+4K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+4K200226RetroFixRetrofix Screws, LLC20200—
+4K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+4K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+4K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K191241AutoStrutOrthospin20194—
+4K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+4K182677DynaNail MiniMedShape, Inc.20195—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+4K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K173883External Fixation SystemLife Spine, Inc.20180—
+4K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+4K173746Activmotion RangeNewclip Technics20181—
+4K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—