510(k) Report

Devices descending from K964024

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K151849Seneka I Polyscrew Pedicle Fixation SystemSenecka Spine20151—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K133066Spineselect Polyscrew Pedicle Screw SystemSpineselect, LLC20140—
+3K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+3K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K123138Pass LP Spinal SystemMedicrea International2013132—
+3K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+3K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+3K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+3K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+3K113396Depuy Pulse Thoracolumbar Screw SystemMedos International SARL20121—
+3K120047Coral Spinal SystemTheken Spine, LLC201214—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+3K111301Instinct Java SystemZimmer Spine201131
+3K110321Tiger Spine SystemCorelink, LLC201183—
+3K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+3K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+3K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+3K070385TI-Tamed Spinal SystemTi-Tamed (Pty), Ltd.20090—
+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—
+3K072605Malibu Spinal SystemSeaspine, Inc.200767—
+3K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+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—
+3K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742—
+3K062912Scient'x Spinal SystemScient'X200736—
+3K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+3K033150Art Posterior Spinal SystemAdvanced Medical Technologies AG20041—
+3K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.200462—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+4K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+4K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—