510(k) Report

Devices descending from K060736

531 later devices reach Smith & Nephew 6.5MM and 8.0MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+4K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+4K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+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—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+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—
+4K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+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—
+4K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+4K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+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—
+4K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+4K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+4K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+4K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+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—
+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—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K202307Activ FuseNewclip Technics20200—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+4K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+4K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+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—
+4K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K191636APTUS Foot SystemMedartis AG20190—
+4K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+4K191241AutoStrutOrthospin20194—
+4K182677DynaNail MiniMedShape, Inc.20195—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K182989AURORA™ Screw SystemMiRus, LLC20180—
+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—
+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—
+4K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+4K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+4K163440Stealth Staple SystemFirst Ray, LLC20173—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+4K153379AxSOS 3TiStryker GmbH201625—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+4K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+4K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+4K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+4K150871ForeFoot STP SystemTornier, Inc.20150—
+4K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+4K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+4K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+4K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+4K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+4K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+4K141992Variax 2 SystemStryker Trauma AG201422—