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
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+4K142499Reline SystemNu Vasive, Incorporated201478—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+4K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K123552Instinct Java SystemZimmer Spine201301
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+4K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+4K122592Instinct Java SystemZimmer Spine201301
+4K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+4K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+4K120696Tiger Spine SystemCorelink, LLC201241—
+4K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K113270Instinct Java SystemZimmer Spine201121
+4K110283Zenius Spinal SystemMedyssey Co, Ltd.201114—
+4K103272Zenius Spinal SystemMedyssey Co, Ltd.201015—
+4K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+4K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+4K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+4K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+4K091189Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20093—
+4K090779Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20090—
+4K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+4K081158Zodic Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20080—
+4K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+4K081228Capsure PS (R) Spine SystemSpine Wave, Inc.200839—
+4K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+4K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+4K072685Ngarde SystemN Spine, Inc.200709
+4K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+4K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+4K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+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—
+5K252322SIros-X SystemGenesys Spine20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—