510(k) Report

Devices descending from K133746

67 later devices reach Polaris Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+1K151974Polaris Spinal SystemBiomet Spine201516—
+1K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+1K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+1K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+2K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+2K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+2K200303Reform Pedicle Screw SystemPrecision Spine202010—
+2K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+2K180433Ennovate®Aesculap Implant Systems, LLC201811
+2K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+2K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+2K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+2K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+3K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+3K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+3K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+3K191575ARx Spinal SystemLife Spine, Inc.201910—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—