510(k) Report

Devices descending from K031302

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K181899Roccia® PlifSilony Medical GmbH20180—
+5K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+5K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+5K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+5K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+5K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+5K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+5K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+5K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+5K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+5K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+5K150847Foundation Interbody DevicesCorelink, LLC201529—
+5K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+5K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+5K133827A-Link ZOsteo Vasive, LLC2014262
+5K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+5K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+5K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+5K133967Interbody Cage SystemAurora Spine2014227—
+5K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+5K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+5K131077Life Spine Plateau Spacer SystemLife Spine201310—
+5K122588Vusion CS PlusOrtho Development Corp.2013206—
+5K124034Mectalif AnteriorMedacta International201311—
+5K123909Aesculap Cespace XPAesculap Implant System, Inc.20137—
+5K122444Cervical CageEisertech, LLC201222—
+5K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+5K113478Plif CageEisertech, LLC2012269—
+5K112862Mecta-CMedacta International201114—
+5K110915Cervical CageEisertech, LLC201123—
+5K100889Endoskeleton TCTitan Spine, LLC2010455—
+5K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K251016MectaLIF 3D MetalMedacta International S.A.20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+6K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+6K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+6K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+6K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+6K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+6K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+6K230026SqualeImplanet, S.A.20230—
+6K223043The Integrity Spine Core SystemIntegrity Spine20230—
+6K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+6K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+6K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+6K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+6K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+6K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+6K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+6K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+6K212831MectaLIF ExtensionMedacta International S.A.20211—
+6K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+6K210359Hexanium TLIFSpinevision, S.A.S.20211—
+6K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+6K200048MectaLIF Anterior SimpleMedacta International S.A.20200—