510(k) Report

Devices descending from K050471

127 later devices reach 4CIS Solar Spine System and 4CIS Apollon Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2011123—
+1K0824534CIS Solar and Apollon Spine SystemsSolco Biomedical Co., Ltd.2008126—
+2K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.20164—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K100373Tyche Pedicle Screw SystemKyung Won Medical Co., Ltd.20104—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—