510(k) Report

Devices descending from K152304

448 later devices reach Tritanium PL Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+4K223251Hexanium PLIFSpinevision, S.A.S.20220—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+4K203003Pantheon IBFDPantheon Spinal20210—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K261067BEE PLIF CageNGMedical GmbH20260—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+5K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K243474MagnetOs MISKuros Biosciences B.V20250—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+5K240453ReBOSSISOrthorebirth Co., Ltd.202402
+5K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—