510(k) Report

Devices descending from K950697

849 later devices reach Depuy Motech Moss Miami Spinal System - Pedicle Fixation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K233300POWEReam 1/4 DriveStryker Instruments20231—
+3K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+3K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K172826Cellent Spinal SystemsJiangsu Trauhui Medical Instrument Co., Ltd.20180—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+3K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+3K162764Jazz Frame SystemImplanet, S.A.20176—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.20160—
+3K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K150684WASTON General Spinal SystemChangzhou Waston Medical Appliance Co., Ltd.20150—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K134011General Spinal SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K140229General Spinal SystemTianjin Walkman Biomaterial Co., Ltd.20140—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K111690Devine Spinal SystemChangzhou Orthmed Medical Instrument Co., Ltd.20113—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+3K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+3K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+3K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+3K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+3K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20071801
+3K072081Zodiac Dynamo Semi-Rigid Spinal SystemAlphatec Spine, Inc.20071—
+3K063668Roc Lumbar SystemAlphatec Spine, Inc.20070—
+3K070368Trio Plate System, Trio Spinal Fixation System, Trio+ Spinal SystemStryker Corp.200787—
+3K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742—