510(k) Report

Devices descending from K920738

346 later devices reach Ace 100 Degrees Tubular Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K191636APTUS Foot SystemMedartis AG20190—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+5K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+5K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+5K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+5K172886Breakaway Screw SystemParagon 2820174—
+5K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+5K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+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—
+5K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+5K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+5K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+5K161448Footmotion Plating SystemNewclip Technics20165—
+5K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+5K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+5K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+5K153379AxSOS 3TiStryker GmbH201625—
+5K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+5K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+5K151407RECON systemNormed Medizin-Technik GmbH20154—
+5K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+5K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+5K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+5K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+5K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+5K141905Pro-Link Wedge SystemLife Spine201411—
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K141992Variax 2 SystemStryker Trauma AG201422—
+5K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+5K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+5K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+5K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+5K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+5K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+6K261191Alians Elbow SNewclip Technics20260—
+6K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+6K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+6K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+6K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+6K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+6K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+6K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+6K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+6K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+6K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+6K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+6K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+6K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+6K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+6K230204ALPHALOK Plating SystemVilex, LLC20230—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+6K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+6K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+6K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+6K221558ALPHALOK Plating SystemVilex, LLC20222—
+6K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+6K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+6K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+6K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+6K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—