510(k) Report

Devices descending from K082252

576 later devices reach Independence Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+7K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+7K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+8K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+8K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+8K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+9K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K230026SqualeImplanet, S.A.20230—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K203003Pantheon IBFDPantheon Spinal20210—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—