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
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K161149PASS OCT Spinal SystemMedicrea International SA20160—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160756PASS OCT Spinal SystemMedicrea International SA20160—
+4K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+4K153169PASS OCT Patient Specific RodsMedicrea International20164—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K142798PASS LP Spinal SystemMedicrea International SA201584—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K150049PASS LP Spinal SystemMedicrea International20150—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K141398Pass LP Spinal SystemMedicrea International SA2015101
+4K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+4K142499Reline SystemNu Vasive, Incorporated201478—
+4K140738Pass LP Spinal SystemMedicrea International201447—
+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—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132574Pass LP Spinal SystemMedicrea International20130—
+4K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+4K132575Pass LP Spinal SystemMedicrea International20130—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123552Instinct Java SystemZimmer Spine201301
+4K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+4K122592Instinct Java SystemZimmer Spine201301
+4K122814Galleon Pedicle Screw SystemEverest Spine, LLC20120—
+4K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+4K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K120696Tiger Spine SystemCorelink, LLC201241—
+4K113058Tiger Spine SystemCorelink, LLC201281—
+4K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+4K113270Instinct Java SystemZimmer Spine201121
+4K110551Expedium Spine SystemJohnson & Johnson20111—
+4K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+4K101070Expedium Spine SystemMedos International SARL20102601
+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—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+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—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+5K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+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—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—