510(k) Report

Devices descending from K031757

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+8K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+8K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+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—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+8K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+8K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+8K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+8K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+8K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+8K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+8K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+8K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+8K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+8K193258ProLift Expandable SystemLife Spine, Inc.20203—
+8K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+8K193174Keos Lumbar IBFDKeos20190—
+8K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+8K192117Small VBR™Ulrich GmbH & Co. KG20196—
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K183064TxTi IBF SystemInnovasis, Inc.2019481
+8K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+8K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+8K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+8K182721Choice Spine Navigation SystemChoicespine, LP20192—
+8K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+8K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+8K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+8K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+8K170235Lucent®Spinal Elements, Inc.2017107—
+8K171321K2M Navigation InstrumentsK2m201711
+8K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+8K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+8K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+8K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+8K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+8K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+8K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+8K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+8K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+8K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+8K152651AccuLIF TL and PL CageStryker Corporation201530—
+8K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+8K152304Tritanium PL CageStryker20154481
+8K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+8K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+8K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+8K141135Juliet LLSpineart2014146—
+8K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+8K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+8K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+8K130445Vault Alif SystemSpinal USA20139—
+8K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+8K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+8K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—