510(k) Report

Devices descending from K101171

225 later devices reach Orthovita Peek Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+1K120486Avs as Peek SpacerStryker Spine2012224—
+2K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K201585Monterey AL Interbody SystemStryker Corporation202044
+2K200312Tryptik TiSpineart20202—
+2K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+2K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+2K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+2K162496Foundation 3D InterbodyCorelink, LLC201782—
+2K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+2K142251AVS AS PEEK SpacerStryker Corporation2014161—
+2K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+3K230026SqualeImplanet, S.A.20230—
+3K230583Tryptik TiSpineart SA20231—
+3K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+3K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+3K183064TxTi IBF SystemInnovasis, Inc.2019481
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K161407Ascential IBD PEEKc SpacerStryker Spine201627—
+3K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K242303MOD-COrthomod, LLC20260—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K223326Axiom PSR SystemRestor3D202301
+4K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+4K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+4K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+4K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K203444BEE HA CageNGMedical GmbH20211—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+4K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K163265Kepler IIOrbbo Surgical, LLC20170—
+4K162694Ayers Rock Cervical interbody fusion systemSpineway20170—
+5K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K250560BEE HANGMedical GmbH20250—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+5K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+5K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—