510(k) Report

Devices descending from K011182

711 later devices reach Modified Moss Miami 4.35MM Diameter Polyaxial Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K231479TriALTIS Spine SystemMedos International SARL20238—
+5K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+5K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K203023Pisces Spinal SystemOrtho Development Corporation20210—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+5K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+5K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+5K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+5K180324Patriot Spinal Fixation SystemValorus Spine20180—
+5K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+5K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K171321K2M Navigation InstrumentsK2m201711
+5K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+5K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+5K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151813Sniper Spine SystemSpine Wave, Inc.20159—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+5K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K132303Implanet Spine SystemImplanet, S.A.201315—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—