510(k) Report

Devices descending from K041939

718 later devices reach Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052670Staxx XD SystemSpine Wave, Inc.20068—
+1K043405Nuvasive Coroent SystemNuvasive, Inc.20057121
+2K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+2K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+2K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+2K102315Staxx XDL SystemSpine Wave, Inc.20113—
+2K111469Staxxsd SystemSpine Wave, Inc.20110—
+2K090315Staxx XD SystemSpine Wave, Inc.20096—
+2K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080—
+2K052210Nuvasive Coroent Extensure SystemNuvasive, Inc.2005263—
+2K051454Aleutian Spacer SystemK2m, LLC2005666—
+3K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+3K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+3K133207Staxx (R) SystemSpine Wave, Inc.20131—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K110843Aleutian Spacer SystemK2m, Inc.2011589—
+3K103666Lanx LateralLanx, Inc.2011238—
+3K101288Staxx XD SystemSpine Wave, Inc.201051
+3K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+3K082698Aleutian Ibf SystemK2m, Inc.2009662—
+3K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+3K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+3K063399Aleutian Spacer SystemK2m, Inc.2007663—
+4K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+4K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K181963ostaPek Interbody Fusion CagesColigne AG20181—
+4K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K163364MOJAVE Expandable Interbody SystemK2m201725—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+4K141135Juliet LLSpineart2014146—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K133614Aleutian Ibf SystemK2m, Inc.2014527—
+4K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+4K133126K7 Lumbar SpacersK7, LLC20131—
+4K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+4K131178Idys Lif CagesClariance201311—
+4K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+4K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+4K130699Aleutian Spinal SystemK2m, Inc.2013570—
+4K123388K7C SpacerK7, LLC20130—
+4K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+4K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+4K113138Aleutian SystemK2m, Inc.2012549—
+4K112664Zavation Ibf SystemsZavation, LLC201137—
+4K103169AleuttianK2m, Inc.2011572—
+4K101302Aleutian Ibf SystemK2m, Inc.2010595—
+5K261049Scala® TLSpineart SA20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K243670Idys® LIFClariance20240—
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+5K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+5K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+5K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K212831MectaLIF ExtensionMedacta International S.A.20211—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+5K201793EDEN Peek CageJmt Co., Ltd.20210—
+5K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—