510(k) Report

Devices descending from K972326

488 later devices reach Peba Anchor/Suture Combination through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+1K123425Twinfix TI 3.5MM Suture Anchor with Two Ultrabraid Suture #2 with Needles, SLSmith & Nephew, Inc.20130—
+1K100159Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div.2010174
+1K083151Extremity Medical Suture AnchorExtremity Medical, LLC20091—
+1K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC20077—
+1K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSmith & Nephew, Inc.2006477—
+1K020159Smith & Nephew Twinfix TI Quick TSmith & Nephew, Inc.200224—
+1K983169Polymer Threaded AnchorOrthopaedic Biosystems, Ltd.19980—
+1K982963Polymer Threaded Anchor / Suture CombinationOrthopaedic Biosystems, Ltd.19984—
+2K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+2K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+2K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+2K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+2K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+2K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+2K193377TopLock Anchor SystemFusion Orthopedics, LLC20200—
+2K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+2K150166Extremity Medical Suture AnchorExtremity Medical, LLC20150—
+2K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+2K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc.201229—
+2K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+2K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+2K102298Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor…Depuy Mitek, A Johnson & Johnson Company201115—
+2K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc.20103—
+2K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+2K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—
+2K101063Sleeve with Ziploop Fixation DevicesBiomet Sports Medicine201031
+2K091870Tornier, Piton Fixation Implant SystemTornier20096—
+2K090128Tac-Tite (TM)Core Essence Orthopaedics, Inc.20091—
+2K082215Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division2008469
+2K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc.200868
+2K071816Harpoon Suture AnchorBiomet Sports Medicine, Inc.20070—
+2K071704Sleeve and Button Soft Tissue DevicesBiomet Sports Medicine, Inc.2007142—
+2K063726PLC Suture AnchorSmith & Nephew Inc., Endoscopy Div.2007122—
+2K061863Arthrex Corkscrew Suture Anchor, Tak, and Pushlock FamilyArthrex, Inc.2006283—
+2K061154Kinsa Suture AnchorSmith & Nephew, Inc.2006162—
+2K023021Modification to Smith & Nephew Twinfix TI Quick TSmith & Nephew, Inc.20027—
+2K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc.20013—
+3K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20261—
+3K251145Arthrex PushLock Suture AnchorsArthrex, Inc.20252—
+3K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek20250—
+3K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+3K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+3K212739ActiFlipParcus Medical, LLC20210—
+3K211002Grappler Suture Anchor SystemParagon 28, Inc.202161
+3K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+3K192949Flower Suture Anchor SetFlower Orthopedics Corporation20200—
+3K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+3K193402ALLthread PEEK Suture AnchorBiomet, Inc.20200—
+3K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+3K192942ALLthread Titanium Suture AnchorBiomet, Inc.20200—
+3K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMedos International SARL20192—
+3K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+3K190474MectaLock PEEK Suture AnchorMedacta International S.A.20190—
+3K182941HEALIX ADVANCE SP PEEK AnchorMedos International SARL20192—
+3K182507Tigon Medical Tissue AnchorsTigon Medical20192—
+3K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+3K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+3K180361MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc.20184—
+3K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+3K172491ICONN Square 2.5MM Suture AnchorIconn Orthopedics, LLC20170—
+3K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+3K162429ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC20175—
+3K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC20161—
+3K153585Flip Button Suture AnchorFirst Ray, LLC20161—
+3K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+3K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+3K143745Arthrex Corkscrew and SwiveLock Suture AnchorsArthrex, Inc.201510—
+3K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company20154—
+3K140855Arthrex Suturetak Suture AnchorsArthrex, Inc.201463—
+3K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+3K141711Pontis 3MM Suture Anchors with Ultra-High Molecular Weight Polyethylene Suture, Pontis…Pontis Orthopaeeics, LLC20140—
+3K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC20141—
+3K133235Threaded Peek K-WireMtp Solutions, LLC20142—
+3K133469Acumed Suture Anchor SystemAcumed, LLC20142—
+3K133229Titanium Suture AnchorMtp Solutions, LLC20142—
+3K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+3K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+3K122635Tornier Insite FT Biocomposite Suture AnchorTornier, Inc.20130—
+3K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors…Biomet Sports Medicine201302
+3K122805Parcus Draw Tight 1.8MM Single-Loaded Suture AnchorParcus Medical, LLC20131—
+3K120155Arthrex Knotless Suturetak AnchorArthrex, Inc.20124—
+3K112814CuffinkCayenne Medical, Inc.20120—
+3K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+3K111716Knotless Suture Fixation SystemCore Essence Orthopaedics20110—
+3K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+3K112237Microsuture AnchorsArthrex, Inc.201177—
+3K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+3K110473Nanotack Suture Anchor 1.4MMPivot Medical20112—
+3K110229Rog Suture Anchor 5.5MM, 2.9MMRog Sports Medicine, Inc.20116—
+3K103712Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ OrthocordDepuy Mitek, A Johnson & Johnson Company20116—
+3K110145Biomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc.2011833
+3K103309Osteoraptor Curved 2.3 Suture AnchorsSmith & Nephew Endoscopy, Inc.20112—
+3K101459Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766…Smith & Nephew, Inc.201110—
+3K101823Arthrex Swivelock AnchorsArthrex, Inc.20111036
+3K101679Arthrex Pushlock AnchorsArthrex, Inc.201041—
+3K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc.20101611
+3K092133Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065NArthrocare Corp.20095—
+3K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp.200910—
+3K083070Toggleloc SystemBiomet Sports Medicine2008946