510(k) Report

Devices descending from K012254

2,058 later devices reach VBR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+7K170235Lucent®Spinal Elements, Inc.2017107—
+7K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+7K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+7K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+7K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+7K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+7K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+7K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+7K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+7K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+7K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+7K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+7K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+7K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+7K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+7K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+7K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+7K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+7K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+7K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+7K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+7K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+7K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+7K163364MOJAVE Expandable Interbody SystemK2m201725—
+7K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+7K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+7K162587Roccia® AcifSilony Medical GmbH20171—
+7K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+7K162764Jazz Frame SystemImplanet, S.A.20176—
+7K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+7K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+7K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+7K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K162264Cascadia Interbody SystemK2m, Inc.2016169—
+7K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201683—
+7K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+7K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+7K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K152622Alta ACDF SystemBiomet Spine20160—
+7K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+7K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+7K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+7K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+7K160125Cascadia Interbody SystemK2m2016315—
+7K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+7K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+7K160547Cascadia Interbody SystemK2m2016157—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153400ProLift Expandable SystemLife Spine, Inc.201672—
+7K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+7K160291Optimus ALIF SystemAmendia, Inc.20160—
+7K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+7K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+7K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+7K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+7K152651AccuLIF TL and PL CageStryker Corporation201530—
+7K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+7K152304Tritanium PL CageStryker20154481
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+7K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+7K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+7K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+7K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+7K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+7K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+7K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+7K142487Chesapeake Stabilization SystemK2m, Inc.201571
+7K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+7K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+7K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+7K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+7K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+7K140734Nextgen Altius Oct SystemEbi, LLC20140—
+7K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+7K141942Midline II TICentinel Spine, Inc.2014459—
+7K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K1421124WEB Spinal Implant Products4Web, Inc.201433—
+7K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+7K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+7K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+7K133200Stalif C (R)Centinel Spine, Inc.201410—