510(k) Report

Devices descending from K961555

584 later devices reach Acufex Tag Bioabsorbable Anchors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+8K241577Iconix® AnchorRiverpoint Medical20240—
+8K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+8K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+8K233659Suture WingOsteonic Co., Ltd.20230—
+8K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+8K233468Iconix AnchorRiverpoint Medical20231—
+8K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+8K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+8K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+8K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+8K231113Arthrex FiberTak Suture AnchorArthrex, Inc.20235—
+8K230568FiberTak Suture AnchorArthrex, Inc.20236—
+8K222423Fixone All Suture AnchorAju Pharm Co., Ltd.202308
+8K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited20230—
+8K230433Arthrex Knotless FiberTak Suture AnchorArthrex, Inc.20230—
+8K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+8K222161Arthrex Knotless FiberTak Biceps Suture AnchorArthrex, Inc.20220—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+8K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+8K192810Apollo Suture Anchor SystemValeris Medical20201—
+8K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+8K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+8K173859HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20184—
+8K172921Stryker Self-Punching ICONIXStryker20170—
+8K151660MultiFIX S Knotless Fixation SystemArthroCare Corporation20151—
+8K132783Exoshape Duo Soft Tissue FastenerMedShape, Inc.20130—
+9K262677Iconix Knotless TRiverpoint Medical20260—
+9K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC20261—
+9K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+9K252144Iconix Speed Anchor; Iconix Speed HA+ AnchorRiverpoint Medical20250—
+9K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+9K243323Iconix Knotless AnchorRiverpoint Medical20240—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K241912BiochargeNanofiber Solutions, LLC20240—
+9K240213Iconix Knotless AnchorRiverpoint Medical20240—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K232742Arthrex FiberTak Suture AnchorArthrex, Inc.20234—
+9K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+9K231330FiberTak® Suture AnchorArthrex, Inc.20235—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223294SpineJack® Expansion KitStryker Instruments20221—
+9K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+9K200949HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL20201—
+9K183506HEALIX ADVANCE Anchor with DYNACORD SutureMedos International SARL20192—
+9K153669MultiFIX S Ultra Knotless Fixation SystemArthocare Corporation20160—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K250637VCFix Spinal SystemAmber Implants20250—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+10K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K203794HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE SutureMedos International SARL20210—
+11K262094E3D™-C Interbody SystemEvolution Spine20260—
+11K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+11K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+11K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+11K260038E3D™-C Interbody SystemEvolution Spine20261—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+11K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+11K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+11K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+12K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+12K242517ProAM ACDF SystemPro Surgical, Inc.20240—