510(k) Report

Devices descending from K083637

791 later devices reach Calix Spinal Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+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—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+8K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230026SqualeImplanet, S.A.20230—
+8K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+8K222561AlignAcuity Surgical Devices, LLC202214—
+8K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+8K220610SOLO-LAurora Spine, Inc.20220—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K200316UNiD IB3D ALIFMedicrea International SA20200—
+8K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+8K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+8K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+8K183243Velofix TLIF CageU&I Corporation20190—
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+8K182349Concorde LiftMedos International SARL20190—
+8K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+8K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+8K173537Concorde Lift™Medos International SARL20181—
+8K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+9K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+9K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+9K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+9K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+9K190680Favo S-TlifSilony Medical GmbH20190—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+10K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+10K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+10K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+10K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+11K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—