510(k) Report

Devices descending from K931155

551 later devices reach Staple, Fixation Bone; Screw Fixation Bone through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+6K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+6K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K253906Xpert HandNewclip Technics20260—
+6K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+6K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+6K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+6K253291Excelsior SystemBlue Ocean Global20260—
+6K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+6K253202Hoffmann LRF SystemStryker GmbH20250—
+6K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+6K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+6K251555Ultra™ Compression Screw SystemPace Surgical20251—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K242988Genostis Osteosynthesis SystemGenostis AF20250—
+6K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+6K243469SignexOsteonic Co., Ltd.20250—
+6K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+6K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+6K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+6K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+6K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+6K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+6K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+6K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+6K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+6K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K231860TDM Screw SystemTdm Co., Ltd.20240—
+6K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+6K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+6K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+6K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+6K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+6K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+6K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+6K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+6K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+6K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K212552Correx SoftwareVilex, LLC20210—
+6K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K211435PAO Cortical ScrewMedacta International S.A.20210—
+6K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+6K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+6K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+6K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+6K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+6K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+6K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+6K202307Activ FuseNewclip Technics20200—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+6K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+6K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+6K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+6K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+6K191636APTUS Foot SystemMedartis AG20190—
+6K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+6K191241AutoStrutOrthospin20194—
+6K182677DynaNail MiniMedShape, Inc.20195—
+6K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+6K182989AURORA™ Screw SystemMiRus, LLC20180—