510(k) Report

Devices descending from K992168

547 later devices reach Moss Miami 6.35MM Polyaxial Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+3K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+3K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+3K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+3K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+3K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K162143FixxSure® X-LinkInnovasis, Inc.20160—
+3K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+3K161369EVEREST Spinal SystemK2m, Incorporated20169—
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K153152Syzygy Stabilization SystemAmendia, Inc.201602
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+3K142499Reline SystemNu Vasive, Incorporated201478—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Amendia, Inc.2014231
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+3K131250Tiger Spine SystemCorelink, LLC201340—
+3K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K123552Instinct Java SystemZimmer Spine201301
+3K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K122592Instinct Java SystemZimmer Spine201301
+3K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+3K120696Tiger Spine SystemCorelink, LLC201241—
+3K113058Tiger Spine SystemCorelink, LLC201281—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K113270Instinct Java SystemZimmer Spine201121
+3K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+3K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+3K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+3K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+3K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+3K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+3K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+3K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+3K081228Capsure PS (R) Spine SystemSpine Wave, Inc.200839—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+3K072685Ngarde SystemN Spine, Inc.200709
+3K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+3K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+3K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—