510(k) Report

Devices descending from K040928

1,504 later devices reach Expandable Peek VBR Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+8K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+8K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+8K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+8K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+8K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+8K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+8K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+8K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+8K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+8K221244CD Horizon™ Spinal SystemMedtronic202220—
+8K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+8K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+8K211740DualXAmplify Surgical, Inc.20211—
+8K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+8K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+8K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+8K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+8K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+8K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—