510(k) Report

Devices descending from K933881

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+4K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+4K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+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—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+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—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+4K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+4K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+4K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171838TiLock2 Spinal SystemGenesys Spine20174—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.20166—
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151977icotec Pedicle SystemIcotec AG201630—
+4K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541