510(k) Report

Devices descending from K031585

579 later devices reach U&I, Optima, Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+3K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K141397Sure-Lok C Extended Tab Pedicle Screw SystemPrecision Spine, Inc.20140—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K133063Santis Pedicle Screw SystemLanterna Medical Technologies20142—
+3K132101Anax 5.5 Spinal SystemU&I Corporation201313—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine201322
+3K131522Core Pedicle Screw SystemCore-Nexus20130—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123373Nautilus Spinal SystemLife Spine201317—
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+3K111953Nautilus Spinal SystemLife Spine20123—
+3K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+3K120538Palls M Spinal SystemKorea Bone Bank Co., Ltd.20121—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K111362Rexious Spinal Fixation SystemDio Medical Co., Ltd.201111—
+3K100373Tyche Pedicle Screw SystemKyung Won Medical Co., Ltd.20104—
+3K090320Conquest Spinal SystemLife Spine20092—
+3K090424DVX Spine SystemBk Meditech, Co., Ltd.20090—
+3K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+4K232628VADER® Pedicle SystemIcotec AG20241—
+4K233960INNOVERSE Spinal SystemInnosys Co., Ltd.20240—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—