510(k) Report

Devices descending from K152304

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+5K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K221578Hexanium ACIFSpinevision, S.A.S.20224—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+5K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+5K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+5K211413BEE PLIF CageNGMedical GmbH20211—
+5K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K210728CONDUIT InstrumentsMedos International SARL20215—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K183092Kuros TLIF CageKuros Biosciences B.V20190—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+6K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+6K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+6K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+6K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+6K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+6K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K213417Ghost Spacer SystemLife Spine, Inc.20220—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—