510(k) Report

Devices descending from K854886

241 later devices reach Wuerzburg Titanium Mini Bone Plates & Bone Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122049Neuropro Low Profile Cranial Plating SystemKinamed, Inc.20130—
+4K121732Canopy Laminoplasty Fixation SystemGlobus Medical, Inc.201210—
+4K120352Stryker Quikflap Sterile Procedure PackStryker2012418
+4K113218Pioneer Release Laminoplasty Plating SystemPioneer Surgical Technology, Inc.20121—
+4K103084Neodent Graft ScrewJjgc Industria E Comercio DE Materiais Dentarios S20110—
+4K100691Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp.20106—
+4K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+4K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+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—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K222367Save GBRDentis Co., Ltd.20230—
+5K182759BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd.20200—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+5K150469Integra Laminoplasty SystemSeaspine, Inc.20151—
+5K140309CranioplugOssdsign AB20142—
+5K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+5K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+5K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc.20135—
+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
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K181539OSSDSIGN CranioplugOssdsign AB20181—
+6K182079Solstice SRS Immobilization System; Solstat Immobilization System; Solstice…Medtec Inc. Dba Civco Medical Solutions201801
+6K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Medtec, Inc. D/B/A Civco Medical Solutions20163—
+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—
+7K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+7K252661SternaFuse Ti Fixation SystemFusion Innovations, LLC20250—
+7K202914SternaFuse Fixation SystemFusion Innovations, LLC20221—
+7K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd.20211—
+7K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+7K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic…Life Technologies Corporation20200—
+7K181806ARIX Sternal SystemJeil Medical Corporation20180—
+7K173579Thorecon™ Fixation SystemA & E Medical Corporation20181—
+7K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesQfix20170—
+7K150581Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201544—
+7K142484Sternal Closure SystemJace Medical, LLC20141—
+7K133785Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc.2014451
+7K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc.201246—
+7K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation201275—
+7K051165KLS Martin Sternal TalonKLS-Martin L.P.200662—
+7K053624Medicon Stern-a-Fix Sternal Closure SystemMedicon EG20060—
+8K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+8K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+8K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd.20230—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+8K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+8K183172Stryker SternalPlate SystemStryker20191—
+8K181607Thorecon Rigid Fixation SystemA & E Medical Corporation201805
+8K161876Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201643—
+8K161896Biomet Microfixation Sternal Closure SystemBiomet Microfixation20164—
+8K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation201543—
+8K142823Biomet Microfixation Thoracic Fixation SystemBiomet Microfixation201523—
+8K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+8K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+9K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+9K243491SternalPlate ExpansionStryker Leibinger GmbH & Co KG20240—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K232829Versalock Rib and Sternum Plates SystemGM Dos Reis Industria e Comercio Ltda.20240—
+9K233967DePuy Synthes MatrixSTERNUM Fixation SystemSynthes GmbH20240—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K212782SternaLock Sternal Closure SystemBiomet Microfixation20220—
+9K193468Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)202040—
+9K182179AdvantageRib Anterior SystemSig Medical Corp.20180—
+9K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation201640—
+9K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+9K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+9K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201611—
+9K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201513—
+9K101484Compressyn BandDallen Medical20115—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+10K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311