510(k) Report

Devices descending from K992961

378 later devices reach Lorenz Small Fragment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+6K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+6K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+6K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+6K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+6K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+6K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+6K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+6K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+6K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+6K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+6K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+6K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+6K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+6K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+6K221395Footmotion Plating SystemNewclip Technics20220—
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+6K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+6K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K211435PAO Cortical ScrewMedacta International S.A.20210—
+6K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+6K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+6K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+6K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+6K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+6K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+6K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+6K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+6K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+6K191636APTUS Foot SystemMedartis AG20190—
+6K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+6K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+6K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+6K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+6K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+6K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+6K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+6K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+6K172886Breakaway Screw SystemParagon 2820174—
+6K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+6K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+6K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+6K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+6K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+6K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+6K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+6K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+6K161448Footmotion Plating SystemNewclip Technics20165—
+6K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+6K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+6K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+6K153379AxSOS 3TiStryker GmbH201625—
+6K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+6K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+6K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+6K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+6K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+6K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+6K151407RECON systemNormed Medizin-Technik GmbH20154—
+6K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+6K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+6K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+6K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+6K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+6K143365Eminent Foot Plate SystemEminent Spine20151—
+6K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+6K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+6K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+6K141905Pro-Link Wedge SystemLife Spine201411—
+6K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+6K141992Variax 2 SystemStryker Trauma AG201422—
+6K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+6K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+6K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+6K122005Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201239—
+6K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+7K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+7K261191Alians Elbow SNewclip Technics20260—
+7K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+7K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+7K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+7K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+7K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—