510(k) Report

Devices descending from K011335

840 later devices reach Synths One-Third Tubular DCL Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253202Hoffmann LRF SystemStryker GmbH20250—
+5K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+5K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+5K250155Xpert KneeNewclip Technics20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+5K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+5K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+5K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+5K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+5K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+5K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+5K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+5K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+5K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+5K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+5K213572JuniOrtho Plating System™Orthofix Srl20220—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K212552Correx SoftwareVilex, LLC20210—
+5K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+5K211435PAO Cortical ScrewMedacta International S.A.20210—
+5K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+5K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+5K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+5K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+5K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+5K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+5K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K203011Monster Screw SystemParagon 28, Inc.20206—
+5K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+5K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+5K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+5K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+5K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+5K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+5K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+5K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+5K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+5K191636APTUS Foot SystemMedartis AG20190—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K191241AutoStrutOrthospin20194—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+5K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+5K182677DynaNail MiniMedShape, Inc.20195—
+5K183317AdvantageRib SystemSig Medical Corporation20194—
+5K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K182989AURORA™ Screw SystemMiRus, LLC20180—
+5K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+5K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+5K173883External Fixation SystemLife Spine, Inc.20180—
+5K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+5K180500VariAx 2 SystemStryker GmbH201812—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+5K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+5K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170—
+5K172262EVOS Small Fragment Plating SystemSmith & Nephew, Inc.20179—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+5K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+5K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+5K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+5K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+5K163440Stealth Staple SystemFirst Ray, LLC20173—
+5K162179osteo-WEDGE II ® Open Wedge Bone Locking Plate SystemGraham Medical Technologies, LLC Dba Gramedica20170—
+5K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+5K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+5K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—