510(k) Report

Devices descending from K113447

691 later devices reach Rise Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K243474MagnetOs MISKuros Biosciences B.V20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+7K242589Scarlet® AL-TSpineart SA20240—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+7K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+7K230989Rod Registration FrameNu Vasive, Incorporated20230—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+7K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230026SqualeImplanet, S.A.20230—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—