510(k) Report

Devices descending from K020522

1,234 later devices reach Modification to Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+7K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+7K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+7K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+7K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+7K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+7K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+7K211413BEE PLIF CageNGMedical GmbH20211—
+7K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+7K200919Idys ALIF 3DTiClariance20210—
+7K202032Idys LLIF 3DTiClariance, Sas20210—
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K200429BEE CagesNGMedical GmbH202111—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+7K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+7K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K192117Small VBR™Ulrich GmbH & Co. KG20196—
+7K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+7K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+7K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+7K191263Idys ALIF TiVacClariance, Sas20190—
+7K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+7K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+7K182349Concorde LiftMedos International SARL20190—
+7K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+7K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052