510(k) Report

Devices descending from K090899

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+9K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K253545Vulcan Spinal SystemK2m, Inc.20260—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K230026SqualeImplanet, S.A.20230—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—