510(k) Report

Devices descending from K983622

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+8K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+8K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+8K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+8K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+8K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+8K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+8K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+8K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+8K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+8K200070ARx Spinal SystemLife Spine, Inc.20209—
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K191575ARx Spinal SystemLife Spine, Inc.201910—
+8K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+8K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+8K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+8K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+8K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+8K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+8K171321K2M Navigation InstrumentsK2m201711
+8K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+8K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+8K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+8K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+8K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+9K230329F3D Interbody SystemCorelink, LLC20230—
+9K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+9K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+9K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+9K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+9K182470Plateau Spacer SystemLife Spine20180—
+9K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+9K161028K2M Growing Spine SystemK2m, Inc.20163—
+9K161369EVEREST Spinal SystemK2m, Incorporated20169—
+9K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+9K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+9K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+10K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—