510(k) Report

Devices descending from K121683

682 later devices reach Acculif TL Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K222561AlignAcuity Surgical Devices, LLC202214—
+9K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+9K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+9K220610SOLO-LAurora Spine, Inc.20220—
+9K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+9K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+9K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+9K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+9K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+9K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+9K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+9K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+9K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+9K203003Pantheon IBFDPantheon Spinal20210—
+9K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+9K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+9K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+9K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+9K202637F3D Corpectomy SystemCorelink, LLC20201—
+9K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+9K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+9K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+9K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K200316UNiD IB3D ALIFMedicrea International SA20200—
+9K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+9K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+9K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+9K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+9K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+9K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+9K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+9K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+9K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+9K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+9K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+9K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+9K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+9K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+9K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+9K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+9K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+9K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+9K182349Concorde LiftMedos International SARL20190—
+9K183092Kuros TLIF CageKuros Biosciences B.V20190—
+9K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+9K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+9K173537Concorde Lift™Medos International SARL20181—
+10K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+10K261279DeltaNEC Interbody SystemNexus Spine20260—
+10K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+10K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K261067BEE PLIF CageNGMedical GmbH20260—
+10K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+10K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+10K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+10K253545Vulcan Spinal SystemK2m, Inc.20260—
+10K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+10K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+10K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+10K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+10K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+10K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+10K253331PressON Spinal Fixation SystemNexus Spine20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+10K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+10K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+10K243474MagnetOs MISKuros Biosciences B.V20250—
+10K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+10K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+10K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+10K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+10K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+10K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+10K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+10K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+10K240453ReBOSSISOrthorebirth Co., Ltd.202402
+10K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+10K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+10K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+10K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+10K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+10K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+10K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+10K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+10K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+10K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—