510(k) Report

Devices descending from K082235

693 later devices reach Blackstone Pillar XL Peek Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+1K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+1K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+1K090166Avs Anterior Large Peek SpacersStryker Corp.2009683—
+2K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+2K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+2K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH2012470—
+2K103814Pezo Interbody Cages SystemUlrich GmbH & Co. KG20114—
+2K093864Avs Align Peek Spacers Model 48328XXX, 48326XXXStryker Corp.2010637—
+3K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+3K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K162986SPIRA Open Matrix ALIFCamber Spine Technologies201711—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+3K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+3K123758Tasmin RSignus Medizintechnik GmbH20141—
+3K131372Mobis IISignus Medizintechnik GmbH2013462—
+3K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+3K122317Tetris IISignus Medizintechnik GmbH20122—
+4K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+4K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K210573Velofix SA Cervical CageU&I Corporation20211—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K192897icotec Cervical CageIcotec AG20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+4K181899Roccia® PlifSilony Medical GmbH20180—
+4K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+4K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+4K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+4K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+4K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+4K152304Tritanium PL CageStryker20154481
+4K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+4K143616AccuLIF TL and PL CageStryker Corporation20154694
+4K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+5K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+5K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+5K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+5K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+5K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+5K191796Neo Cage SystemNeo Medical SA20190—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K181048Neo Cage System TMNeo Medical SA20191—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+5K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+5K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+5K162262Tritanium® PL CageStryker2016132—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K160955Tritanium® PL CageStryker2016178—
+5K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+5K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+5K160125Cascadia Interbody SystemK2m2016315—
+5K152651AccuLIF TL and PL CageStryker Corporation201530—
+5K150481Cascadia Interbody SystemK2m, Inc.20154593
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+6K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—