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
+1K021626Hallu PlatesNew Deal, S.A.2002280—
+1K963741Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc.1997188—
+1K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997144—
+2K112794Eos Small Bone Fixation SystemTriMed, Inc.201294
+2K093781Modified: Newdeal Hallu PlatesNewdeal Sas20101—
+2K083154Newdeal Hallu Lock Plate SystemNewdeal Sas200921
+2K050681Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc.200592—
+2K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004249—
+2K032534Synthes AfsSynthes Spine200443—
+2K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997143—
+3K252930AQUA Laminoplasty SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+3K252061Distal Xtremities SystemTriMed, Inc.20250—
+3K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+3K250948TriMed Fusion Cup SystemTriMed, Inc.20250—
+3K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20231—
+3K231232Curiteva Laminoplasty SystemCuriteva, Inc.20232—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+3K191927Hinged Laminoplasty SystemLife Spine, Inc.20190—
+3K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+3K181717Life Spine Laminoplasty SystemLife Spine, Inc.20181—
+3K173215Choice Spine Laminoplasty™ Fixation SystemChoicespine, LP20184—
+3K153395OS2-C Compression StapleIn2bones Sas20167—
+3K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+3K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+3K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+3K132740Spinefrontier Lesplasty Posterior Cervical Laminoplasty SystemSpinefrontier, Inc.20130—
+3K130510Arthrex Compression PlatesArthrex, Inc.20138—
+3K122822Spectrum Spine Laminoplasty Plating SystemSpectrum Spine, LLC20135—
+3K121276Neuro Vention Laminplasty Plating SystemNeurovention, LLC20120—
+3K111048Synthes Scout Tack FixationSynthes Spine20120—
+3K113802Escalate Laminoplasty SystemStryker Spine20127—
+3K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K111266Easylock OsteosystemTriMed, Inc.20110—
+3K103284Laminoplasy Plating SystemAesculap Implant Systems, Inc.20101—
+3K100805Gallery Laminoplasty Fixation SystemBiomet Spine (Aka Ebi, LLC)20103—
+3K091994Mountaineer Laminoplasty SystemDepuy Spine, Inc.201017—
+3K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+3K091623Laminoplasty Fixation SystemNuvasive, Inc.20097—
+3K090354Laminoplasty Plating SystemAesculap Implant System, Inc.20092—
+3K080664Relieve Laminoplasty Fixation SystemGlobus Medical, Inc.200811—
+3K073342Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc.20085—
+3K052614Low Profile Plate and Screw SystemArthrex, Inc.2005245—
+3K052152B-Bop PlateNew Deal, S.A.20051—
+3K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+3K043338Blakstone Laminoplasty Fixation SystemBlackstone Medical, Inc.200517—
+3K0232601.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp.200224—
+3K992106Modus System Self-Drilling ScrewsMedartis AG19990—
+3K974785Auto-Drive Bone ScrewOsteomed Corp.1998141—
+4K262344Large Compression ScrewsTriMed, Inc.20260—
+4K261241TriMed Compression ScrewsTriMed, Inc.20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical20240—
+4K243137Curiteva Porous PEEK Laminoplasty SystemCuriteva, Inc.20241—
+4K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC20240—
+4K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+4K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+4K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+4K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+4K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+4K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+4K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+4K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+4K201235Arthrex MaxForce MTP Compression Plates and ScrewsArthrex, Inc.20200—
+4K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209—
+4K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174—
+4K171413HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc.20176—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K163440Stealth Staple SystemFirst Ray, LLC20173—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K160114Xspan Laminoplasty Fixation SystemX-Spine Systems, Inc.20160—
+4K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+4K153735Release Laminoplasty Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20160—
+4K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.20150—
+4K151195OsteoMed IMF ScrewOsteomed20150—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+4K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+4K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+4K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+4K141764Tristar Bone Graft Fixation SystemImpladent, Ltd.20143—
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K131061Restore Bunion Correction SystemNextremity Solutions201315—
+4K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+4K130830Integra Laminoplasty SystemSeaspine, Inc.20132—