510(k) Report

Devices descending from K041888

1,586 later devices reach Curved Peek Tetris Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+8K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+8K240715Idys® C ZP 3DTiClariance20240—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+8K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+8K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+8K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+8K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+8K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+8K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+8K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+8K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+8K221244CD Horizon™ Spinal SystemMedtronic202220—
+8K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+8K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+8K211740DualXAmplify Surgical, Inc.20211—
+8K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+8K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+8K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+8K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+8K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+8K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+8K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+8K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+8K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+8K193258ProLift Expandable SystemLife Spine, Inc.20203—
+8K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+8K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+8K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+8K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+8K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+8K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+8K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+8K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+8K181963ostaPek Interbody Fusion CagesColigne AG20181—
+8K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+8K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+8K172568CervagePrecifit Medical, Ltd.20181—
+8K172115Navigated Instrument SystemOrthofix, Inc.20184—
+8K173508Everest Spinal SystemK2m20189—
+8K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+8K170235Lucent®Spinal Elements, Inc.2017107—
+8K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+8K171425Concorde LiftMedos International SARL201782
+8K162921Navigated Instrument SystemOrthofix, Inc.20175—
+8K163180Hubble IIOrbbo Surgical, LLC20160—
+8K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+8K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+8K153400ProLift Expandable SystemLife Spine, Inc.201672—