510(k) Report

Devices descending from K062810

835 later devices reach Solitaire Anterior Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K170235Lucent®Spinal Elements, Inc.2017107—
+7K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+7K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+7K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+7K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+7K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+7K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+7K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+7K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+7K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+8K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+8K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+8K200312Tryptik TiSpineart20202—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K1803473d CageFims Co., Ltd.20190—
+8K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+8K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+8K182584Lucent® XPSpinal Elements, Inc.20183—
+8K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+8K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+8K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+8K172816TiGer Shark™ SystemChoicespine, LP201859—
+8K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+8K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+8K172419Velofix™ TLIF CageU&I Corporation20172—
+8K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+8K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—