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
+5K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+5K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+5K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+5K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K131833Centurion Poct SystemOrthofix, Inc.20142—
+5K132603Apex Spine SystemSpinecraft, LLC201325—
+5K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+5K130176Firebird Spinal Fixation SystemOrthofix20135—
+5K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+5K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+5K120564Calypso SystemHogan Lovells US LLP201216—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K240963Spinal SystemTeslake, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+6K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+6K203023Pisces Spinal SystemOrtho Development Corporation20210—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+6K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+6K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+6K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+6K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+6K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+6K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+6K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+6K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+6K150417Astra Spine SystemSpinecraft, LLC201521—
+6K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+6K132303Implanet Spine SystemImplanet, S.A.201315—
+6K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+7K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240392JAZZ Spinal SystemImplanet20241—
+7K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+7K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+7K211323ASTRA Spine SystemSpinecraft, LLC202112—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—