510(k) Report

Devices descending from K965145

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K193219G Surgical Marksman SystemG Surgical, LLC20191—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+7K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+8K200070ARx Spinal SystemLife Spine, Inc.20209—
+9K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+9K210549ARx Spinal SystemLife Spine, Inc.20211—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—