510(k) Report

Devices descending from K031302

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192906Mecta-C Stand AloneMedacta International S.A.20201—
+6K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+6K1803473d CageFims Co., Ltd.20190—
+6K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+6K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+6K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+6K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+6K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K172480icotec Interbody Cage SystemIcotec AG20185—
+6K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+6K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+6K172816TiGer Shark™ SystemChoicespine, LP201859—
+6K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+6K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+6K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+6K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+6K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+6K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+6K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+6K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+6K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+6K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+6K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+6K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+6K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+6K160154ALTA Anterior Cervical Interbody SpacerAstura Medical201663—
+6K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+6K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+6K142744Mecta-C TiPEEKMedacta International201512—
+6K140348Interbody CageEisertech, LLC2015235—
+6K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+6K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+6K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+6K133717Longbow Spacer SystemLife Spine20149—
+6K132738Cogent Med-LifCogent Spine, LLC201413—
+6K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+6K131178Idys Lif CagesClariance201311—
+6K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+6K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+6K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+6K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+6K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+7K2530413d Cage CervicalFims Co., Ltd.20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K261067BEE PLIF CageNGMedical GmbH20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+7K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+7K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+7K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K243670Idys® LIFClariance20240—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223326Axiom PSR SystemRestor3D202301
+7K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+7K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+7K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—
+7K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+7K221172FOCUS Interbody SystemOc Medical Devices20220—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K213417Ghost Spacer SystemLife Spine, Inc.20220—
+7K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+7K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+7K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+7K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+7K210573Velofix SA Cervical CageU&I Corporation20211—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112