510(k) Report

Devices descending from K000066

713 later devices reach Synthes (Usa) Locking Condylar Plate (LCP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+5K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230805TriMed Clavicle Fixation SystemTriMed, Inc.20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K230527WishBone Medical Plate and Screw SystemWishbone Medical, Inc.20230—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+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—
+5K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+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—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K212552Correx SoftwareVilex, LLC20210—
+5K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K211435PAO Cortical ScrewMedacta International S.A.20210—
+5K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+5K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+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—
+5K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+5K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.20210—
+5K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+5K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+5K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K203011Monster Screw SystemParagon 28, Inc.20206—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+5K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+5K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+5K191636APTUS Foot SystemMedartis AG20190—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K191241AutoStrutOrthospin20194—
+5K191009Arsenal Plating SystemTrilliant Surgical20192—
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K190430OsteoCentric Bone Plate and Screw SystemOsteocentric Trauma20192—
+5K182677DynaNail MiniMedShape, Inc.20195—
+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—
+5K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+5K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+5K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+5K172886Breakaway Screw SystemParagon 2820174—
+5K172350AxSOS 3 TiStryker GmbH201717—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+5K170727VariAx 2 Compression Plating SystemStryker GmbH20172—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+5K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+5K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+5K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.20170—
+5K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+5K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+5K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+5K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+5K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+5K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+5K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+5K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—