510(k) Report

Devices descending from K040928

1,504 later devices reach Expandable Peek VBR Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+9K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+9K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+9K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K241895Cannulated PsiFGuardSpineguard20240—
+9K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+9K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+9K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+9K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+9K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+9K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+9K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+9K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+9K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+9K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+9K213815SiJoin®T3Vgi Medical, Inc.20230—
+9K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+9K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+9K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+9K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+9K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+9K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+9K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+9K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+9K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+9K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+9K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+9K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+9K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+9K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+9K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+9K193258ProLift Expandable SystemLife Spine, Inc.20203—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+9K190721LongBow TiLife Spine, Inc.20190—
+9K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+9K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+9K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+9K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+9K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+9K180376K2M Patient Specific RodsK2m, Inc.20182—
+9K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+9K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+9K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+9K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+9K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+9K171519FLXfit™Expanding Orthopedics, Inc.2017711
+9K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+9K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+9K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+9K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+9K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+9K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+9K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+9K162262Tritanium® PL CageStryker2016132—
+9K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+9K161028K2M Growing Spine SystemK2m, Inc.20163—
+9K161369EVEREST Spinal SystemK2m, Incorporated20169—
+9K160955Tritanium® PL CageStryker2016178—
+9K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+9K160715AccuLIF TL and PL CageStryker Corporation20160—
+9K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+9K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+9K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—