510(k) Report

Devices descending from K082128

933 later devices reach Depuy Spine Lateral Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+9K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K202637F3D Corpectomy SystemCorelink, LLC20201—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K253545Vulcan Spinal SystemK2m, Inc.20260—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+10K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+11K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—