510(k) Report

Devices descending from K031757

1,702 later devices reach Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+9K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+9K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+9K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+9K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+9K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+9K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+9K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+9K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+9K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+9K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+9K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+9K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+9K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+9K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+9K221244CD Horizon™ Spinal SystemMedtronic202220—
+9K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+9K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+9K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+9K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+9K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+9K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+9K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+9K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+9K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+9K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+9K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+9K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+9K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+9K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+9K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+9K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+9K182584Lucent® XPSpinal Elements, Inc.20183—
+9K181963ostaPek Interbody Fusion CagesColigne AG20181—
+9K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+9K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+9K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+9K172115Navigated Instrument SystemOrthofix, Inc.20184—
+9K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+9K171425Concorde LiftMedos International SARL201782
+9K162921Navigated Instrument SystemOrthofix, Inc.20175—
+9K163180Hubble IIOrbbo Surgical, LLC20160—
+9K162262Tritanium® PL CageStryker2016132—
+9K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+9K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+9K160955Tritanium® PL CageStryker2016178—
+9K160715AccuLIF TL and PL CageStryker Corporation20160—
+9K153400ProLift Expandable SystemLife Spine, Inc.201672—
+9K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+9K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+9K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+9K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+9K130194Acculif XL CageCoalign Innovations, Inc.20131—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+10K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K250403Catamaran SI Joint Fusion SystemTenon Medical20251—