510(k) Report

Devices descending from K981274

597 later devices reach Acromed Timx Plate Based Low Back System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+6K131343Reform Pedicle Screw SystemSpinal USA201331—
+6K130279Reform Pedicle Screw SystemSpinal USA201331—
+6K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+6K123373Nautilus Spinal SystemLife Spine201317—
+6K111953Nautilus Spinal SystemLife Spine20123—
+6K090320Conquest Spinal SystemLife Spine20092—
+7K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K232628VADER® Pedicle SystemIcotec AG20241—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+7K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+7K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+7K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+7K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K221244CD Horizon™ Spinal SystemMedtronic202220—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+7K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K193129Yukon OCT Spinal SystemK2m, Inc.202001
+7K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+7K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+7K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+7K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K183381Navigation Enabled InstrumentsStryker20191—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+7K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K162921Navigated Instrument SystemOrthofix, Inc.20175—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+7K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+7K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—