510(k) Report

Devices descending from K961421

462 later devices reach Synthes 2.4 MM Universal Locking Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+7K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+7K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+7K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+7K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+7K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+7K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+7K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+7K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+7K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+7K161448Footmotion Plating SystemNewclip Technics20165—
+7K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+7K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+7K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+7K153379AxSOS 3TiStryker GmbH201625—
+7K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+7K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+7K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+7K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+7K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+7K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+7K151407RECON systemNormed Medizin-Technik GmbH20154—
+7K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+7K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+7K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+7K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+7K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+7K143365Eminent Foot Plate SystemEminent Spine20151—
+7K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+7K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+7K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+7K141905Pro-Link Wedge SystemLife Spine201411—
+7K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+7K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+7K141992Variax 2 SystemStryker Trauma AG201422—
+7K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+7K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+7K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+7K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+7K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+8K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+8K261191Alians Elbow SNewclip Technics20260—
+8K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+8K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+8K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+8K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+8K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+8K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+8K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+8K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+8K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K240487EVOS Patella PlatesSmith & Nephew20240—
+8K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+8K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+8K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+8K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+8K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+8K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+8K230204ALPHALOK Plating SystemVilex, LLC20230—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+8K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+8K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+8K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+8K221558ALPHALOK Plating SystemVilex, LLC20222—
+8K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+8K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+8K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+8K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+8K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+8K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+8K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+8K213214Xpert WristNewclip Technics20210—