510(k) Report

Devices descending from K130177

628 later devices reach Anatomic Peek Cervical Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+6K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+6K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K203003Pantheon IBFDPantheon Spinal20210—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K210728CONDUIT InstrumentsMedos International SARL20215—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+6K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+6K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+6K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+6K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+6K182349Concorde LiftMedos International SARL20190—
+6K173537Concorde Lift™Medos International SARL20181—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+7K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+7K250556Porous Biologic ScaffoldVentris Medical20250—
+7K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+7K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+7K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K240458Synthetic Bone PuttyVentris Medical20242—
+7K240459Cerament Bone Void FillerBonesupport AB20240—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+7K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+7K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+7K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223494CD Horizon Spinal SystemMedtronic202317—
+8K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+8K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—