510(k) Report

Devices descending from K082698

662 later devices reach Aleutian Ibf System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K151756Sterispine LC CageSafe Orthopaedics20150—
+4K142392Zavation Posterior LEIFZavation, LLC20150—
+4K142271Zavation Z-Link LumbarZavation, LLC20149—
+4K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+4K141005Z-Link CervicalZavation, LLC20144—
+4K133893Sterispine LC CageSafe Orthopaedics20141—
+5K261279DeltaNEC Interbody SystemNexus Spine20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+5K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+5K250556Porous Biologic ScaffoldVentris Medical20250—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+5K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+5K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+5K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+5K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+5K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+5K240442MagnetOs PuttyKuros Biosciences B.V20243—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K240715Idys® C ZP 3DTiClariance20240—
+5K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+5K240458Synthetic Bone PuttyVentris Medical20242—
+5K240459Cerament Bone Void FillerBonesupport AB20240—
+5K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K232347MagnetOs GranulesKuros Biosciences B.V20242—
+5K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+5K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+5K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+5K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K232315Catalyst Bone Void FillerOssdsign AB20237—
+5K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+5K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+5K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+5K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K230026SqualeImplanet, S.A.20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+5K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+5K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—