510(k) Report

Devices descending from K980447

381 later devices reach Depuy Motech Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K071438PSS SystemSpinal USA200739—
+1K062785LTD Polyaxial Fixation SystemUs Spine200641—
+1K023498Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2002300—
+1K020674Blackstone Spinal Fixation System 4.5MM Multi-Axial ScrewBlackstone Medical, Inc.2002305—
+1K013558Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc.2002304—
+1K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc.1998251—
+1K980484Aesculap Spine System EvolutionAesculap, Inc.1998251—
+2K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+2K131343Reform Pedicle Screw SystemSpinal USA201331—
+2K130279Reform Pedicle Screw SystemSpinal USA201331—
+2K122931S-Lok PSS SystemSpinal USA20120—
+2K121172Reform Pedicle Screw SystemSpinal USA201233—
+2K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+2K092128Modification to: PSS SystemSpinal USA200936—
+2K090033Modification to: PSS SystemSpinal USA200937—
+2K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc.20082773
+2K081296Preference Pedicle Screw SystemUs Spine20083—
+2K073240PSS SystemSpinal USA200836—
+2K080407Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc.20082961
+2K062912Scient'x Spinal SystemScient'X200736—
+2K042514Modification to Blackstone Modular Pedicle Screw SystemBlackstone Medical, Inc.200412
+2K030581Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc.2003298—
+2K030241Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2003297—
+2K022605Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc.2002302—
+2K022399Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc.2002300—
+2K001080Spine System EvolutionAesculap, Inc.200062—
+2K990118Isobar Spinal SystemScien'Tx USA, Inc.1999250—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+3K170647Connector SystemOrthofix, Inc.201718—
+3K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+3K160362Z-Span Plate SystemZavation, LLC20163—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K141397Sure-Lok C Extended Tab Pedicle Screw SystemPrecision Spine, Inc.20140—
+3K133369Tiger Spine SystemCorelink, LLC201429—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC20120—
+3K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K110321Tiger Spine SystemCorelink, LLC201183—
+3K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+3K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+3K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+3K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+3K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc.2008209—
+3K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+3K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+3K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+3K051063Polyaxial Hemispherical Spinal ScrewsScient'X200537—
+3K040747Aladyn Rigid Spine PlateScient'X20040—
+3K033150Art Posterior Spinal SystemAdvanced Medical Technologies AG20041—
+3K030087Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc.20030—
+3K030667Encore Anterior Spinal Staple SystemEncore Medical L.P.20030—
+3K020245Modification to Isobar Spinal SystemScien'Tx USA, Inc.200243—
+3K013444Isobar Spinal SystemScien'Tx USA, Inc.200194—
+3K991326Isobar Semi-Rigid Spinal SystemScien'Tx USA, Inc.19992—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+4K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—