510(k) Report

Devices descending from K081917

1,008 later devices reach Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+5K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+5K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+5K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+5K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+5K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+5K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+5K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+5K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+5K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+6K263049SABER-C SystemElevation Spine20260—
+6K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+6K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+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—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+6K243188Cylox® STSignus Medizintechnik GmbH20250—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+6K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+6K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+6K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+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—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+6K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+6K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+6K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+6K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+6K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+6K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+6K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+6K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+6K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K222561AlignAcuity Surgical Devices, LLC202214—
+6K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+6K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+6K220610SOLO-LAurora Spine, Inc.20220—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+6K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—