510(k) Report

Devices descending from K022793

1,705 later devices reach Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+7K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+7K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+7K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+7K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+7K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+7K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+7K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+7K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+7K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+7K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+7K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+7K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+7K122047Alamo PAlliance Partners, LLC20120—
+7K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+7K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+7K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+7K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+7K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+7K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+7K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+7K111569Plateau Spacer SystemLife Spine2011181—
+7K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+7K110927MectalifMedacta International2011301
+7K103111Forza Spacer SystemOrthofix, Inc.20113431
+7K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+7K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+7K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+7K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+7K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+7K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+7K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+7K082801Phantom Plus Cage SystemUs Spine2008643—
+7K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+7K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+7K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+8K263049SABER-C SystemElevation Spine20260—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K261430TruLift Expandable SystemLife Spine, Inc.20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+8K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+8K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+8K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—