510(k) Report

Devices descending from K031635

1,201 later devices reach Depuy Acromed VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K2530413d Cage CervicalFims Co., Ltd.20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K261279DeltaNEC Interbody SystemNexus Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K261067BEE PLIF CageNGMedical GmbH20260—
+6K260660SABER-C SystemElevation Spine20261—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+6K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+6K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+6K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K250540SABER-C SystemElevation Spine20252—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K243816Testa TP Pivoting Spacer SystemSpine Wave, 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—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+6K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242589Scarlet® AL-TSpineart SA20240—
+6K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+6K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+6K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+6K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+6K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+6K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+6K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+6K240453ReBOSSISOrthorebirth Co., Ltd.202402
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+6K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+6K232069Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd.20230—
+6K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+6K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+6K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation20230—
+6K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+6K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+6K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+6K223251Hexanium PLIFSpinevision, S.A.S.20220—
+6K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+6K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+6K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—