510(k) Report

Devices descending from K935448

469 later devices reach Luhr Mini Bone Screw and Z Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+6K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+6K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K230546SignexOsteonic Co., Ltd.20242—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+6K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+6K222367Save GBRDentis Co., Ltd.20230—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+6K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+6K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+6K221485Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20225—
+6K213837Arthrx Fracture PlatesArthrex, Inc.20220—
+6K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+6K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K203239Arthrex Low Profile ScrewsArthrex, Inc.20200—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+6K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+6K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+6K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+6K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+6K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+6K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+6K162171S4 Screw System™Subchondral Solutions20173—
+6K170547Arthrex Mesh Plate SystemArthrex, Inc.201715—
+6K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+6K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+6K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+6K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+6K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+6K170382Arthrex Compression ScrewsArthrex, Inc.20173—
+6K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+6K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie20170—
+6K151732Arthrex Fracture PlatesArthrex, Inc.201521—
+6K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+6K140037Optimus CMF SystemOsteonic Co., Ltd.20152—
+6K143139Arthrex Fracture SystemArthrex, Inc.20151—
+6K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc.2014381
+6K131775Universal Neuro 3 SystemStryker20130—
+6K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation20130—
+6K131620Jones-FX Fracture SystemInstratek, Inc.20131—
+6K122334Checkmate Small Bone Fusion SystemArthrosurface, Inc.20125—
+6K120352Stryker Quikflap Sterile Procedure PackStryker2012418
+6K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc.201178—
+6K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc.2011841
+6K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine20111—
+6K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003100—
+7K262975Arthrex Beaming SystemArthrex, Inc.20260—
+7K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+7K261511Xpert AnkleNewclip Technics20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260761APTUS Clavicle System 2.8Medartis AG20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+7K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+7K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+7K254182AsterOsteonic Co., Ltd.20260—
+7K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd.20250—
+7K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+7K252661SternaFuse Ti Fixation SystemFusion Innovations, LLC20250—
+7K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+7K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+7K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+7K243469SignexOsteonic Co., Ltd.20250—