510(k) Report

Devices descending from K992276

171 later devices reach Modification to Silhouette Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022374Cadence Spinal Fixation SystemSulzer Spine-Tech2002841
+1K020196Modification to Silhouette Spinal Fixation SystemSulzer Spine-Tech20020—
+1K012173Device Modification of Silhouette Spindal Fixation SystemSulzer Spine-Tech20010—
+1K993067Silhouette Spinal Fixation SystemSulzer Spine-Tech1999111—
+2K133291ST360 Degrees Spinal Fixation SystemZimmer Spine, Inc.20131—
+2K112684Mont Blanc Pedicle Screw SystemsQualgenix20125—
+2K080241DDS Stabilization SystemParadigm Spine, LLC20085—
+2K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+2K072183ST360 Spinal Fixation System, Model 07.0029-7500.5600Zimmer Spine, Inc.200727—
+2K041925ST360 Spinal Fixation SystemZimmer Spine, Inc.2004831
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K151977icotec Pedicle SystemIcotec AG201630—
+3K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150—
+3K150185Mont Blanc Spinal SystemSpineway20154—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+3K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+3K101083DSS Stabilization SystemParadigm Spine, LLC20102—
+3K091944Modification to: DSS Stabilization SystemParadigm Spine, LLC20093—
+3K090408Modification to: DSS Stabilization SystemParadigm Spine, LLC20094—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742—
+3K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+4K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+4K080767Conquest Spinal SystemLife Spine200821—
+4K081228Capsure PS (R) Spine SystemSpine Wave, Inc.200839—
+4K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+4K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+5K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K232628VADER® Pedicle SystemIcotec AG20241—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K231658VEOS Spinal Fixation SystemSpineway20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+5K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+5K100605Mis SystemSpine Wave, Inc.201033—
+5K090320Conquest Spinal SystemLife Spine20092—
+5K083353Capsure (R) PS SystemSpine Wave, Inc.200836—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—