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
+4K122049Neuropro Low Profile Cranial Plating SystemKinamed, Inc.20130—
+4K121732Canopy Laminoplasty Fixation SystemGlobus Medical, Inc.201210—
+4K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+4K113218Pioneer Release Laminoplasty Plating SystemPioneer Surgical Technology, Inc.20121—
+4K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+4K111326Osteowedge Opening Wedge Bone Locking SystemGraham Medical Technologies, LLC20111—
+4K103705Low Profile ScrewsArthrex, Inc.2011219—
+4K103084Neodent Graft ScrewJjgc Industria E Comercio DE Materiais Dentarios S20110—
+4K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+4K063831Basal Dorsal PlatesNewdeal Sas20070—
+4K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+4K031659Universal Neuro SystemStryker Instruments200312—
+4K030806Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20035—
+4K022890Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for…Bioplate, Inc.20027—
+4K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002117—
+5K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+5K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+5K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+5K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230971APTUS® 3.5 TriLock Straight PlatesMedartis AG20232—
+5K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+5K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+5K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K183232Double ENDOBUTTON Fixation DeviceSmith and Nephew, Inc.20196—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K170697GBR systemSurgident20182—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+5K170313ARIX Ankle Distal Tibia SystemJeil Medical Corporation20172—
+5K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K162179osteo-WEDGE II ® Open Wedge Bone Locking Plate SystemGraham Medical Technologies, LLC Dba Gramedica20170—
+5K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K143721PRCT2Fx Solutions20150—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K150469Integra Laminoplasty SystemSeaspine, Inc.20151—
+5K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+5K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+5K143614Arthrex Low Profile ScrewsArthrex, Inc.201519—
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K141478Arthrex Fracture Plates and ScrewsArthrex, Inc.2014231
+5K133662Smith & Nephew Cannulated Captured ScrewSmith & Nephew, Inc.20148—
+5K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+5K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140—
+5K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+5K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+5K132217Arthrex Compression FT ScrewsArthrex, Inc.201318—
+5K131186Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSynthes (USA) Products, LLC20138—
+5K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+5K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+5K121589Biomet Microfixation Facial Plating SystemBiomet Microfixation201251
+5K112557Stryker Universal Neuro 3 SystemStryker20129—
+5K112437Arthrex Fracture SystemArthrex, Inc.201191—
+5K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011135—
+5K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+5K091812Frontier Devices Craniomaxillofacial, Cranio Closure, Orthognathic, Mandible…Frontier Devices, Inc.20104—
+5K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.200687—
+5K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc.2003101—
+5K031751Rapidfire Self Drilling ScrewsWalter Lorenz Surgical, Inc.200301
+5K031028The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20030—
+6K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+6K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K254215Arthrex Beaming SystemArthrex, Inc.20261—