510(k) Report

Devices descending from K983485

171 later devices reach Synthes 1.3 MM Self-Drilling Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K212782SternaLock Sternal Closure SystemBiomet Microfixation20220—
+6K210360Neuro Plating System, Neuro Plating System Plates (NST304M02A and 61 Models), Neuro…Osteonic Co., Ltd.20220—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K193468Tritium Sternal Cable Plate SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)202040—
+6K182179AdvantageRib Anterior SystemSig Medical Corp.20180—
+6K181539OSSDSIGN CranioplugOssdsign AB20181—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+6K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+6K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation201640—
+6K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+6K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+6K152253Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201611—
+6K151173Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation201513—
+6K101484Compressyn BandDallen Medical20115—
+7K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+7K221412ARIX Rib SystemJeil Medical Corporation20221—
+7K192592Axis Plating SystemExtremity Medical, LLC20190—
+7K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation20168—
+7K130431Compressyn BandDallen Medical, Inc.20134—
+8K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+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—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K212608RibFix Blu Thoracic Fixation SystemBiomet Microfixation20224—
+8K190409MatrixRIB Fixation SystemDePuy Synthes20193—
+8K133858Tensyn BandDallen Medical, Inc.20143—
+9K261054RibPlate SystemStryker Leibinger GmbH & Co KG20260—
+9K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+9K252166RIB LINK™ Fixation SystemGlobus Medical, Inc.20260—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K241282RibFix Titan™ Fixation SystemRiverpoint Medical20240—
+9K190963DePuy Synthes Craniomaxillofacial Sternal Devices - MR ConditionalSynthes (USA) Products, LLC20190—
+9K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+10K143092Tensyn PlugDallen Medical, Inc.20151—
+11K150359Tensyn PlugDallen Medical, Inc.20150—