510(k) Report

Devices descending from K103287

348 later devices reach Synthes 6.0 Cocr and CPT TI-3 Rods through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K252437JAZZ Spinal SystemImplanet20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240392JAZZ Spinal SystemImplanet20241—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+4K180376K2M Patient Specific RodsK2m, Inc.20182—
+4K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+4K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+4K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+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—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—