510(k) Report

Devices descending from K961555

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031685Tag Rod Bioraptor Suture Anchor 7209317, 7209318Smith & Nephew, Inc.20034785
+1K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc.1998166—
+2K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+2K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+2K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+2K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSmith & Nephew, Inc.2006477—
+2K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377—
+2K020056Duet Suture AnchorBionx Implants, Ltd.200278—
+2K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc.199886—
+3K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+3K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—
+3K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+3K123425Twinfix TI 3.5MM Suture Anchor with Two Ultrabraid Suture #2 with Needles, SLSmith & Nephew, Inc.20130—
+3K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+3K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc.201229—
+3K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+3K101063Sleeve with Ziploop Fixation DevicesBiomet Sports Medicine201031
+3K091870Tornier, Piton Fixation Implant SystemTornier20096—
+3K082215Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division2008469
+3K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.200868
+3K071816Harpoon Suture AnchorBiomet Sports Medicine, Inc.20070—
+3K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc.2007142—
+3K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC20077—
+3K063726PLC Suture AnchorSmith & Nephew Inc., Endoscopy Div.2007122—
+3K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc.2006283—
+3K061154Kinsa Suture AnchorSmith & Nephew, Inc.2006162—
+3K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+3K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd.200476—
+3K042517Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd.20040—
+3K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P.200273—
+3K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc.20025—
+3K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments199979—
+3K982721Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc.19996—
+4K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20261—
+4K251145Arthrex PushLock Suture AnchorsArthrex, Inc.20252—
+4K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+4K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+4K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+4K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+4K212739ActiFlipParcus Medical, LLC20210—
+4K193377TopLock Anchor SystemFusion Orthopedics, LLC20200—
+4K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+4K192949Flower Suture Anchor SetFlower Orthopedics Corporation20200—
+4K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+4K193402ALLthread PEEK Suture AnchorBiomet, Inc.20200—
+4K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+4K192942ALLthread Titanium Suture AnchorBiomet, Inc.20200—
+4K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMedos International SARL20192—
+4K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+4K190474MectaLock PEEK Suture AnchorMedacta International S.A.20190—
+4K182941HEALIX ADVANCE SP PEEK AnchorMedos International SARL20192—
+4K182507Tigon Medical Tissue AnchorsTigon Medical20192—
+4K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+4K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+4K180361MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc.20184—
+4K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+4K172491ICONN Square 2.5MM Suture AnchorIconn Orthopedics, LLC20170—
+4K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+4K162429ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC20175—
+4K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC20161—
+4K153585Flip Button Suture AnchorFirst Ray, LLC20161—
+4K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K143745Arthrex Corkscrew and SwiveLock Suture AnchorsArthrex, Inc.201510—
+4K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company20154—
+4K140855Arthrex Suturetak Suture AnchorsArthrex, Inc.201463—
+4K133235Threaded Peek K-WireMtp Solutions, LLC20142—
+4K133469Acumed Suture Anchor SystemAcumed, LLC20142—
+4K133229Titanium Suture AnchorMtp Solutions, LLC20142—
+4K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+4K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+4K122635Tornier Insite FT Biocomposite Suture AnchorTornier, Inc.20130—
+4K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine201302
+4K120155Arthrex Knotless Suturetak AnchorArthrex, Inc.20124—
+4K112814CuffinkCayenne Medical, Inc.20120—
+4K113109Stryker Resorbable Fixation SystemStryker20113—
+4K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+4K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+4K112237Microsuture AnchorsArthrex, Inc.201177—
+4K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+4K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+4K110473Nanotack Suture Anchor 1.4MMPivot Medical20112—
+4K110229Rog Suture Anchor 5.5MM, 2.9MMRog Sports Medicine, Inc.20116—
+4K110145Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc.2011833
+4K103309Osteoraptor Curved 2.3 Suture AnchorsSmith & Nephew Endoscopy, Inc.20112—
+4K101459Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766…Smith & Nephew, Inc.201110—
+4K101823Arthrex Swivelock AnchorsArthrex, Inc.20111036
+4K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.20103—
+4K101679Arthrex Pushlock AnchorsArthrex, Inc.201041—
+4K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+4K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc.20101611
+4K092133Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065NArthrocare Corp.20095—
+4K092898Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI SuturesConmed Linvatec20090—
+4K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.2009561
+4K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp.200910—
+4K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp.20090—
+4K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc.20091—
+4K083070Toggleloc SystemBiomet Sports Medicine2008946
+4K081893Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp.200816—
+4K0815112.0 PK Suture Anchor T, 2.0 PK Suture Anchor SSmith & Nephew, Inc.20083—