510(k) Report

Devices descending from K032064

1,280 later devices reach Theken Cpod/Lpod Vertebral Body Replacement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+1K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+1K072326Ostapek VBR SystemCo-Ligne AG20081—
+1K071031VU E*Pod Vertebral Body ReplacementTheken Spine, LLC2007119—
+1K062151Box Peek VBR SystemInnovasis, Inc.2006175—
+1K050997Expanse Vertebral Body Replacement DeviceFlexuspine, Inc.20050—
+1K043479MC+ Partial VBRLdr Spine USA20051,214—
+1K050058Theken Reveal VBR SystemTheken Surgical,Llc2005727—
+2K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+2K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+2K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+2K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+2K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+2K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K173893TrabisColigne AG20180—
+2K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K123758Tasmin RSignus Medizintechnik GmbH20141—
+2K132718Integrity Spine Core SystemIntegrity Spine20131—
+2K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+2K123388K7C SpacerK7, LLC20130—
+2K121581Box Peek VBR System,Innovasis, Inc.20121—
+2K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+2K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+2K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+2K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+2K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+2K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+2K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+2K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+2K082712Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC2009118—
+2K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+2K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC20087081
+2K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+2K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+2K070786X-Pod Adjustable Vertebral Body ReplacementTheken Spine, LLC20070—
+2K070381Theken VU Mesh VBR SystemTheken Spine, LLC200725—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+3K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+3K243188Cylox® STSignus Medizintechnik GmbH20250—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+3K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+3K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+3K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+3K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+3K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+3K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+3K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+3K173148ACIFColigne AG20171—
+3K172323Omnia Medical VBROmnia Medical, LLC20176—
+3K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+3K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+3K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+3K162206Zavation IBFZavation, LLC201724—
+3K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+3K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+3K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—
+3K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+3K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—