510(k) Report

Devices descending from K011182

711 later devices reach Modified Moss Miami 4.35MM Diameter Polyaxial Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+7K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+7K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243693NEO Pedicle Screw System™Neo Medical SA20240—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+7K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+7K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+7K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+7K191217Jazz PFImplanet, S.A.20190—
+7K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K171881JAZZ Passer BandImplanet, S.A.20170—
+7K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+7K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+8K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+8K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K183381Navigation Enabled InstrumentsStryker20191—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—