510(k) Report

Devices descending from K142152

280 later devices reach Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+6K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+6K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+7K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+7K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+8K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+8K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+8K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+9K260810Anteralign LS coverplateTyber Medical, LLC20260—
+9K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+9K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+9K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+9K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+9K223494CD Horizon Spinal SystemMedtronic202317—
+9K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+9K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+9K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+9K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+10K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+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—
+10K252742Navigated InstrumentsTyber Medical, LLC20251—
+10K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+10K253331PressON Spinal Fixation SystemNexus Spine20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+10K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+10K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+10K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+11K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+11K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+11K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+11K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+11K252322SIros-X SystemGenesys Spine20250—
+11K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+11K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+11K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+12K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+13K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—