510(k) Report

Devices descending from K073320

1,018 later devices reach Cimplicity Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081917Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard SystemsDepuy Spine, Inc.20091,008—
+1K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+2K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+2K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+2K173148ACIFColigne AG20171—
+2K170890TELIX K Interbody SystemBiedermann Motech GmbH & Co. KG20170—
+2K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+2K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+2K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+2K140066Infill CervicalPinnacle Spine Group, LLC20140—
+2K133321Alamo CAlliance Partners, LLC20143—
+2K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+2K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+2K131671MectalifMedacta International201322—
+2K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+2K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P.2012405—
+2K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+2K120517Depuy Pulse Cervical Cage SystemMedos International SARL20123—
+2K112696Twin Peaks Lumbar CageQualgenix, LLC20120—
+2K120024Mectalif TransforaminalMedacta International S.A.201223—
+2K112862Mecta-CMedacta International201114—
+2K113348Cougar SystemJohnson & Johnson2011591—
+2K111119Trabecular Metal (TM) Fusion DeviceZimmer Spine, Inc.201152—
+2K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+2K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+2K110694Concorde Bullet Spinal SystemJohnson & Johnson2011227—
+2K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+2K110843Aleutian Spacer SystemK2m, Inc.2011589—
+2K110927MectalifMedacta International2011301
+2K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602—
+2K102606Avs Anchor-C Cervical Cage SystemStryker Spine20113841
+2K103169AleuttianK2m, Inc.2011572—
+2K103488Concorde Bullet Cage SystemJohnson and Johnson201129—
+2K101923Concorde Curve SystemDepuy Spine2010609—
+2K093093Small Plateau Spacer SystemLife Spine2010393—
+2K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+2K101302Aleutian Ibf SystemK2m, Inc.2010595—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K242303MOD-COrthomod, LLC20260—
+3K251016MectaLIF 3D MetalMedacta International S.A.20250—
+3K241073DZ-Tabone Intervertebral Body Fusion DeviceShenzhen Dazhou Medical Technology Co., Ltd.20240—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K212831MectaLIF ExtensionMedacta International S.A.20211—
+3K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+3K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+3K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K190284Bengal Stackable Cage SystemMedos International SARL20190—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181397DualXInnovasive, Inc.201815—
+3K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K172568CervagePrecifit Medical, Ltd.20181—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K173128Alamo® CAlliance Partners, LLC20182—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K172020Arlington PLIF/TLIF CageSignature Orthopaedics Pty, Ltd.20170—
+3K170235Lucent®Spinal Elements, Inc.2017107—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+3K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+3K163180Hubble IIOrbbo Surgical, LLC20160—
+3K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K160547Cascadia Interbody SystemK2m2016157—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+3K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+3K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—