510(k) Report

Devices descending from K982320

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+4K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+4K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+4K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+4K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+4K100605Mis SystemSpine Wave, Inc.201033—
+4K083353Capsure (R) PS SystemSpine Wave, Inc.200836—
+4K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K231658VEOS Spinal Fixation SystemSpineway20230—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+5K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203452Nano FortiFix® SystemNanovis, LLC20200—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K190751Connector SystemOrthofix, Inc.20193—
+5K182721Choice Spine Navigation SystemChoicespine, LP20192—
+5K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173508Everest Spinal SystemK2m20189—
+5K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—