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
+1K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine20250—
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+1K133690True Spinal Fussion SystemInnovative Surgical Designs20140—
+1K133103Aversion Pedicle Screw SystemK7, LLC20140—
+1K130958True Spinal Fixation SystemInnovative Surgical Designs20131—
+1K123717UcentumUlrich GmbH & Co. KG2013171
+1K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122—
+1K113173Nanovis Spinal SystemNanovis, LLC20122—
+1K110046Athena Pedicle Screw SystemRoyal Oak Medical Devices20110—
+1K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+1K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+1K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+1K093833Kapss Spinal SystemRobert Reid, Inc.20100—
+1K100377Diamondback Spinal SystemEminent Spine201029—
+1K061342Malibu Spinal SystemSeaspine, Inc.2006801
+1K051942Malibu Spinal SystemSeaspine, Inc.20058111
+1K051663Malibu Spinal SystemSeaspine, Inc.200581—
+1K042143Excella-M Spinal SystemInnovasis, Inc.20046—
+1K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003410—
+1K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed2002294—
+1K013444Isobar Spinal SystemScien'Tx USA, Inc.200194—
+2K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+2K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+2K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+2K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+2K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+2K203452Nano FortiFix® SystemNanovis, LLC20200—
+2K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+2K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+2K193219G Surgical Marksman SystemG Surgical, LLC20191—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+2K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+2K180324Patriot Spinal Fixation SystemValorus Spine20180—
+2K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+2K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+2K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+2K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+2K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+2K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+2K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+2K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+2K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K151849Seneka I Polyscrew Pedicle Fixation SystemSenecka Spine20151—
+2K151727Everest Spinal SystemK2m, Inc.201511—
+2K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+2K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+2K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+2K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+2K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+2K133066Spineselect Polyscrew Pedicle Screw SystemSpineselect, LLC20140—
+2K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+2K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+2K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+2K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+2K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K113361Securis Spinal FixationCumtom Spine20120—
+2K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+2K120047Coral Spinal SystemTheken Spine, LLC201214—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+2K111301Instinct Java SystemZimmer Spine201131
+2K110321Tiger Spine SystemCorelink, LLC201183—
+2K111099Issys LP Spinal Fixation SystemCustom Spine, Inc.201111
+2K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+2K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+2K070385TI-Tamed Spinal SystemTi-Tamed (Pty), Ltd.20090—
+2K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+2K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+2K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+2K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824—
+2K072605Malibu Spinal SystemSeaspine, Inc.200767—
+2K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.200721
+2K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+2K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20071801
+2K072081Zodiac Dynamo Semi-Rigid Spinal SystemAlphatec Spine, Inc.20071—
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+2K063668Roc Lumbar SystemAlphatec Spine, Inc.20070—
+2K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742—
+2K062912Scient'x Spinal SystemScient'X200736—
+2K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+2K033150Art Posterior Spinal SystemAdvanced Medical Technologies AG20041—
+2K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.200462—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—