510(k) Report

Devices descending from K082358

428 later devices reach Smith & Nephew, Inc. Patient Matched Technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142381Xia 3 Spinal SystemStryker Corp.201483—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+4K140027Zimmer Patient Specific Instruments/ System/PlannerMaterialise NV201412—
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K133162Zimmer Patient Specific Instruments System, Zimmer Patient Specific Instruments, Zimmer…Materialise NV201413—
+4K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+4K132603Apex Spine SystemSpinecraft, LLC201325—
+4K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+4K130126Signature Personalized Patient Care System - Glenoid Guide SystemBiomet, Inc.201338—
+5K260116CustoMED ViewerCustoMED, Ltd.20260—
+5K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K253793Materialise TKA Guide SystemMaterialise NV20260—
+5K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+5K243509Archer PSI System3D-Side20250—
+5K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV20251—
+5K242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.20240—
+5K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+5K240415Newclip Patient-matched instrumentation non sterile PSINewclip Technics20242—
+5K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+5K233874tmCMF SolutionTechmah Cmf20240—
+5K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+5K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+5K230850United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc.20230—
+5K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K221615Newclip Patient-matched instrumentation non sterile PSINewclip Technics20233—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+5K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+5K230276TECHFIT DISRP® SystemTechfit Digital Surgery20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+5K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—
+5K220366EmbedMed3D Lifeprints UK, Ltd.20220—
+5K220648OMF ASP SystemVha Dean20220—
+5K221104Actera™ hip systemConformis, Inc.202211
+5K213684SurgiCase ViewerMaterialise NV20221—
+5K220717RedPoint Medical's Better Bunion SystemRedpoint Medical, LLC20223—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K210347VSP System3D Systems20211—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K201052KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20200—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K192979KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.20202—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K192198Conformis Hip SystemConformis, Inc.2019121
+5K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+5K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+5K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+5K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K260206SkeletonPlannerUPlanner B.V. - Presurgeo20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium…Materialise NV20260—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—