510(k) Report

Devices descending from K031914

1,530 later devices reach Spinal Concepts, Inc. Cadence and Fortitude through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242589Scarlet® AL-TSpineart SA20240—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+8K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+8K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+8K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+8K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+8K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+8K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+8K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+8K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+8K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+8K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+8K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+8K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+8K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+8K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+8K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+8K223326Axiom PSR SystemRestor3D202301
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K230583Tryptik TiSpineart SA20231—
+8K223043The Integrity Spine Core SystemIntegrity Spine20230—
+8K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+8K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+8K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+8K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+8K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+8K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+8K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+8K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+8K221244CD Horizon™ Spinal SystemMedtronic202220—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+8K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+8K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.20220—
+8K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+8K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+8K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+8K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+8K212825CoreLink Navigation InstrumentsCorelink, LLC20214—