510(k) Report

Devices descending from K062759

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K162262Tritanium® PL CageStryker2016132—
+7K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+7K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.20163—
+7K161028K2M Growing Spine SystemK2m, Inc.20163—
+7K161369EVEREST Spinal SystemK2m, Incorporated20169—
+7K160955Tritanium® PL CageStryker2016178—
+7K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+7K160715AccuLIF TL and PL CageStryker Corporation20160—
+7K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+7K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+7K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+7K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+7K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+7K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+7K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K141217Acculif TL and PL CageStryker Corporation20146423
+7K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K263049SABER-C SystemElevation Spine20260—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K250560BEE HANGMedical GmbH20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+8K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+8K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+8K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+8K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+8K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+8K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K234150Lucent® XPSpinal Elements20240—
+8K240715Idys® C ZP 3DTiClariance20240—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+8K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+8K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+8K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+8K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K211993Z-LINKPC SystemZavation Medical Products, LLC20210—