510(k) Report

Devices descending from K023644

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+1K131980Sequoia Pedicle Screw System Including Speedlink II Transverse Connector SystemZimmer Spine, Inc.201310—
+1K072672Sequoia Spinal System, Model 3300 SeriesAbbott Spine, Inc.200702
+1K030087Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc.20030—
+1K030625Spinal Concepts Inc. PathfinderSpinal Concepts, Inc.20031096
+2K203507Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.20218—
+2K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150—
+2K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+2K113044Synthes MirsSynthes Spine2011933
+2K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+2K071174Pathfinder System Polyaxial Pedicle ScrewsAbbott Spine, Inc.2007944
+2K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+2K042640Uni-Thread Spinal SystemSpine Vision, Inc.20040—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K230116Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20235—
+3K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+3K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+3K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+3K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120571Synthes Uss ConnectorSynthes Spine201274—
+3K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+4K240539Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20244—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+4K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K200070ARx Spinal SystemLife Spine, Inc.20209—