510(k) Report

Devices descending from K011406

2,048 later devices reach Spinal Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K243188Cylox® STSignus Medizintechnik GmbH20250—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K243249TriALTIS™ Spine SystemMedos International SARL20250—
+8K243693NEO Pedicle Screw System™Neo Medical SA20240—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+8K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+8K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+8K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+8K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+8K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233300POWEReam 1/4 DriveStryker Instruments20231—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K233684TriALTIS™ Spine SystemMedos International SARL20234—
+8K231515MySpine Cervical GuidesMedacta International S.A.20230—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+8K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+8K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+8K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+8K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+8K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+8K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+8K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+8K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+8K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+8K230614Cortium™Ulrich Medical USA20230—
+8K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+8K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+8K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+8K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+8K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—