510(k) Report

Devices descending from K041888

1,586 later devices reach Curved Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+6K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+6K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+6K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+6K120869Anchor-L Lumbar CageStryker Spine2012638—
+6K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+6K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+6K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+6K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+6K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+6K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+6K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+6K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+6K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+6K121116Plateau Spacer SystemLife Spine201213—
+6K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+6K120656Everest Spinal SystemK2m, Inc.201243—
+6K120024Mectalif TransforaminalMedacta International S.A.201223—
+6K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+6K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+6K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+6K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+6K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+6K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+6K103369Vault Alif SystemSpinal USA201110—
+6K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+6K093093Small Plateau Spacer SystemLife Spine2010393—
+6K101301Stalif MidlineCentinel Spine2010474—
+6K083475Lucent MagnumSpinal Elements, Inc.2009834—
+6K081711Lucent Magnum+Spinal Elements, Inc.20080—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261430TruLift Expandable SystemLife Spine, Inc.20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+7K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+7K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+7K250556Porous Biologic ScaffoldVentris Medical20250—
+7K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+7K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+7K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+7K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+7K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+7K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+7K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+7K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+7K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+7K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+7K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+7K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+7K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K240442MagnetOs PuttyKuros Biosciences B.V20243—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+7K240458Synthetic Bone PuttyVentris Medical20242—
+7K240459Cerament Bone Void FillerBonesupport AB20240—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K232347MagnetOs GranulesKuros Biosciences B.V20242—
+7K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—