510(k) Report

Devices descending from K000594

446 later devices reach Locking Screw Mandibular Reconstruction Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K153379AxSOS 3TiStryker GmbH201625—
+8K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+8K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+8K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+8K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+8K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+8K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+8K151407RECON systemNormed Medizin-Technik GmbH20154—
+8K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+8K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+8K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+8K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+8K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+8K143365Eminent Foot Plate SystemEminent Spine20151—
+8K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+8K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+8K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+8K141905Pro-Link Wedge SystemLife Spine201411—
+8K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+8K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+8K141992Variax 2 SystemStryker Trauma AG201422—
+8K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+8K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+8K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+8K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+8K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+9K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+9K261191Alians Elbow SNewclip Technics20260—
+9K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+9K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+9K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+9K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+9K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+9K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+9K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+9K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+9K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+9K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+9K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K240487EVOS Patella PlatesSmith & Nephew20240—
+9K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+9K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+9K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K234031Medline UNITE Ancillary Foot Recon Plating SystemMedline Industires, LP20241—
+9K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+9K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+9K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+9K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+9K230204ALPHALOK Plating SystemVilex, LLC20230—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+9K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+9K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+9K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+9K221558ALPHALOK Plating SystemVilex, LLC20222—
+9K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+9K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+9K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+9K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+9K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+9K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+9K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+9K213214Xpert WristNewclip Technics20210—
+9K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+9K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+9K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+9K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+9K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+9K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+9K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+9K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+9K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+9K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+9K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+9K201149CoLink Plating SystemIn2bones USA, LLC20200—
+9K200226RetroFixRetrofix Screws, LLC20200—
+9K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+9K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+9K191867ATLAS Plating SystemMiRus, LLC20200—