510(k) Report

Devices descending from K031302

911 later devices reach Sustain Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+8K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+8K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+8K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+8K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+8K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+8K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+8K200919Idys ALIF 3DTiClariance20210—
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+8K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+8K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+8K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+8K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+8K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+8K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+8K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+8K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+8K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+8K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+8K191134IB3D AlifMedicrea International SA20191—
+8K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+8K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+8K190680Favo S-TlifSilony Medical GmbH20190—
+8K183243Velofix TLIF CageU&I Corporation20190—
+8K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+8K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K182608Oyster ACIF CageSilony Medical GmbH20190—
+8K191263Idys ALIF TiVacClariance, Sas20190—
+8K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+8K182477Cervical SpacerAdditive Implants, LLC201915—
+8K181829Velofix TLIF CageU&I Corporation20181—
+8K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+8K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+8K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+8K180695FBC 921 (Alif)Fbc Device Aps20180—
+8K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+8K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+8K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+8K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+8K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+8K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+8K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+8K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+8K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+8K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+8K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+8K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+8K161129Pillar SA PTCOrthofix, Inc.201619—
+8K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+8K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+8K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+8K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+8K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+8K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+8K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+8K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+8K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+8K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+8K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+8K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+9K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+9K260810Anteralign LS coverplateTyber Medical, LLC20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+9K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K253331PressON Spinal Fixation SystemNexus Spine20250—
+9K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+9K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—