510(k) Report

Devices descending from K955348

1,019 later devices reach Titanium Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K123138Pass LP Spinal SystemMedicrea International2013132—
+4K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+4K122592Instinct Java SystemZimmer Spine201301
+4K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+4K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+4K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+4K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+4K120899Range Spinal System, Unit RodK2m, Inc.201235—
+4K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K121020Viper SystemDepuy Spine, Inc.201294—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+4K113044Synthes MirsSynthes Spine2011933
+4K113270Instinct Java SystemZimmer Spine201121
+4K110551Expedium Spine SystemJohnson & Johnson20111—
+4K111913Capsure (R) PS SystemSpine Wave, Inc.20111—
+4K111571Viper SystemsJohnson & Johnson2011203—
+4K110284Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd.201112—
+4K103147Novel Iii Spinal Fixation and Adjustable Bridge SystemMedyssey Co, Ltd.201013—
+4K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+4K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+4K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+4K093104Medyssey CO., LTD., Zenius Spinal SystemMedyssey Co, Ltd.201020—
+4K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2010168—
+4K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+4K100138Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20100—
+4K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+4K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.2009170—
+4K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+4K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+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—
+4K080767Conquest Spinal SystemLife Spine200821—
+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—
+4K043001MX Polyaxial Pedicle ScrewScient'X200437—
+4K042964MX Monoaxial Pedicle ScrewScient'X200438—
+4K042953Modification to Protex Stabilization SystemGlobus Medical, Inc.20040—
+5K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+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—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+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
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+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—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+5K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+5K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+5K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—