510(k) Report

Devices descending from K041888

1,586 later devices reach Curved Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+5K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+5K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+5K172065Scarlet AC-TSpineart20172—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K163589SIGN IM NailSign Fracture Care International20170—
+5K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+5K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+5K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+5K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+5K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+5K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+5K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+5K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+5K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+5K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+5K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+5K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+5K153621Juliet® TiSpineart2016751
+5K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+5K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+5K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+5K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+5K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+5K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+5K160291Optimus ALIF SystemAmendia, Inc.20160—
+5K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+5K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+5K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+5K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+5K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+5K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+5K151654Prow FusionNlt Spine, Ltd.20151—
+5K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+5K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+5K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+5K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+5K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+5K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+5K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+5K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+5K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+5K141798Sypher Spacer SystemBiogennix, LLC20151—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+5K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+5K1421124WEB Spinal Implant Products4Web, Inc.201433—
+5K133717Longbow Spacer SystemLife Spine20149—
+5K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+5K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+5K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+5K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+5K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+5K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+5K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+5K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+5K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+5K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+5K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+5K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+5K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+5K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+5K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+5K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+5K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+5K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+5K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+5K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+5K131671MectalifMedacta International201322—
+5K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+5K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+5K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+5K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—