510(k) Report

Devices descending from K090899

932 later devices reach Depuy Spine Lateral System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243188Cylox® STSignus Medizintechnik GmbH20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+6K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+6K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+6K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+6K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+6K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+6K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+6K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+6K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+6K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+6K223326Axiom PSR SystemRestor3D202301
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+6K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+6K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+6K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+6K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+6K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+6K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+6K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+6K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+6K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+6K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—