510(k) Report

Devices descending from K081395

854 later devices reach Solitaire Peek-Optima Anterior Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+1K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+1K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+1K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+1K093808Incite Innovation Stand Alone Interbody Fusion DeviceIncite Innovation, LLC2010113—
+1K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+1K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+1K083475Lucent MagnumSpinal Elements, Inc.2009834—
+2K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+2K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+2K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+2K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+2K201671A-Link ZAcuity Surgical Devices, LLC202125—
+2K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+2K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+2K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+2K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+2K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+2K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+2K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+2K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+2K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+2K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+2K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+3K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+3K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K240715Idys® C ZP 3DTiClariance20240—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K222561AlignAcuity Surgical Devices, LLC202214—
+3K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K220610SOLO-LAurora Spine, Inc.20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K212562Idys-C ZP 3DTiClariance, SA20211—
+3K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+3K181818Scarlet AL-TSpineart201864—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+3K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K152622Alta ACDF SystemBiomet Spine20160—
+3K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+3K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K141798Sypher Spacer SystemBiogennix, LLC20151—
+3K141942Midline II TICentinel Spine, Inc.2014459—
+3K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+3K133286Midline (TM)Centinel Spine, Inc.2014460—
+3K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+3K124034Mectalif AnteriorMedacta International201311—
+3K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+3K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+3K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+3K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261408SABER-XA SystemElevation Spine20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K242303MOD-COrthomod, LLC20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+4K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K242589Scarlet® AL-TSpineart SA20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—