510(k) Report

Devices descending from K062759

1,406 later devices reach Paramount VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+7K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+7K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+7K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+7K250556Porous Biologic ScaffoldVentris Medical20250—
+7K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+7K243188Cylox® STSignus Medizintechnik GmbH20250—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+7K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+7K241895Cannulated PsiFGuardSpineguard20240—
+7K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+7K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+7K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+7K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+7K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+7K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+7K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+7K240442MagnetOs PuttyKuros Biosciences B.V20243—
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+7K240458Synthetic Bone PuttyVentris Medical20242—
+7K240459Cerament Bone Void FillerBonesupport AB20240—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K232347MagnetOs GranulesKuros Biosciences B.V20242—
+7K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+7K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+7K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+7K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+7K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+7K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+7K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+7K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+7K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K232315Catalyst Bone Void FillerOssdsign AB20237—
+7K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+7K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+7K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+7K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+7K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+7K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+7K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+7K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+7K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+7K213815SiJoin®T3Vgi Medical, Inc.20230—
+7K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+7K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+7K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+7K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+7K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+7K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+7K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—