510(k) Report

Devices descending from K992147

451 later devices reach Triple-Fix Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+5K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+5K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+5K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201189—
+5K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+5K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+5K100297Pass LP Spinal SystemMedicrea Technologies2010136—
+5K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+5K081296Preference Pedicle Screw SystemUs Spine20083—
+6K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+6K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K252322SIros-X SystemGenesys Spine20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+6K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K203023Pisces Spinal SystemOrtho Development Corporation20210—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+6K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+6K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+6K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+6K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+6K172469TiLock Modular Spinal SystemGenesys Spine20170—
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+6K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+6K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+6K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+6K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+6K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+6K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+6K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+6K123552Instinct Java SystemZimmer Spine201301
+6K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+6K112493Pass LP Spinal SystemMedicrea International20111—
+6K110497Pass LP Spinal SystemMedicrea International20111331
+6K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201188—
+6K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—