510(k) Report

Devices descending from K001340

2,423 later devices reach Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+7K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+7K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K241258Ingenix Spinal SystemIngenium Spine20240—
+7K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+7K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+7K240453ReBOSSISOrthorebirth Co., Ltd.202402
+7K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+7K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+7K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+7K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+7K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+7K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+7K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+7K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+7K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+7K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+7K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+7K221745Sterile Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20220—
+7K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+7K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+7K213918DeGen Navigated InstrumentationDegen Medical20220—
+7K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+7K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+7K201793EDEN Peek CageJmt Co., Ltd.20210—
+7K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+7K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+7K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+7K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+7K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+7K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+7K193219G Surgical Marksman SystemG Surgical, LLC20191—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—