510(k) Report

Devices descending from K112036

775 later devices reach Calix PC Spinal Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+1K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+1K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC20162—
+1K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+1K133218Crystal ®; Mosaic ®; Vertu ®Spinal Elements, Inc.2014130—
+1K140066Infill CervicalPinnacle Spine Group, LLC20140—
+1K133653Anatomic Peek PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.2014286—
+1K132596Proposed OptimusCustom Spine, Inc.201451
+1K133192Mectalif TipeekMedacta International201416—
+1K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+1K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+1K110632Lucent or Lucent MagnumSpinal Elements, Inc.20126941
+2K242303MOD-COrthomod, LLC20260—
+2K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+2K251016MectaLIF 3D MetalMedacta International S.A.20250—
+2K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+2K212831MectaLIF ExtensionMedacta International S.A.20211—
+2K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+2K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+2K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+2K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+2K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+2K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+2K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+2K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+2K192906Mecta-C Stand AloneMedacta International S.A.20201—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K183092Kuros TLIF CageKuros Biosciences B.V20190—
+2K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+2K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+2K182584Lucent® XPSpinal Elements, Inc.20183—
+2K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+2K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC20180—
+2K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+2K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+2K172568CervagePrecifit Medical, Ltd.20181—
+2K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+2K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+2K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+2K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+2K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+2K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+2K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+2K160528ANATOMIC PEEK PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201623—
+2K160291Optimus ALIF SystemAmendia, Inc.20160—
+2K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+2K143685Hedgehog Cervical Interbody Fusion DeviceVertera, Inc.201523—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K143740Battalion Universal Spacer SystemAlphatec Spine, Inc.2015247—
+2K150061Lucent; Lucent Ti-Bond SystemsSpinal Elements, Inc.2015135—
+2K142744Mecta-C TiPEEKMedacta International201512—
+2K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+2K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+2K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+2K133967Interbody Cage SystemAurora Spine2014227—
+2K122967LucentSpinal Elements, Inc.2013615—
+3K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K234150Lucent® XPSpinal Elements20240—
+3K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+3K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K230583Tryptik TiSpineart SA20231—
+3K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+3K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+3K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K211306LabyrinthZavation Medical Products, LLC20213—
+3K203254Lucent 3D Spinal SystemSpinal Elements, Inc.20218—
+3K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+3K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K192897icotec Cervical CageIcotec AG20201—