510(k) Report

Devices descending from K983622

328 later devices reach Bodyform Thoraco-Lumbar Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+6K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+6K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+6K131343Reform Pedicle Screw SystemSpinal USA201331—
+6K130279Reform Pedicle Screw SystemSpinal USA201331—
+6K131030Range Spinal SystemK2m, Inc.201334—
+6K130330Range Spinal SystemK2m, Inc.201336—
+6K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+6K123373Nautilus Spinal SystemLife Spine201317—
+6K111953Nautilus Spinal SystemLife Spine20123—
+6K090320Conquest Spinal SystemLife Spine20092—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K221244CD Horizon™ Spinal SystemMedtronic202220—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+7K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+7K193219G Surgical Marksman SystemG Surgical, LLC20191—
+7K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+7K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+7K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K162921Navigated Instrument SystemOrthofix, Inc.20175—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+7K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+7K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+7K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+7K132361Everest Spinal SystemK2m, Inc.201334—
+7K131784Range Spinal SystemK2m, Inc.201334—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—