510(k) Report

Devices descending from K972783

166 later devices reach Biofix Biodegradable Threaded Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377—
+1K020056Duet Suture AnchorBionx Implants, Ltd.200278—
+1K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc.199886—
+2K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+2K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd.200476—
+2K042517Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd.20040—
+2K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P.200273—
+2K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc.20025—
+2K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments199979—
+2K982721Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc.19996—
+3K113109Stryker Resorbable Fixation SystemStryker20113—
+3K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+3K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+3K092898Conmed Linvatec Presto Preloaded with One or Two #2 HI-FI SuturesConmed Linvatec20090—
+3K091549Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp.2009561
+3K090835Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRLinvatec Corp.200910—
+3K090186Conmed Linvatec Paladin, Preloaded with Two #2 HI-FI SuturesLinvatec Corp.20090—
+3K080862Sonicweld RX (Resorb-X)KLS-Martin L.P.20084—
+3K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+3K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20073—
+3K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+3K051236Resorb-X SFKLS-Martin L.P.20056—
+3K012486Osteomed Bioresorbable Fixation SystemOsteomed Corp.20020—
+4K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+4K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+4K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+4K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+4K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants20222—
+4K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+4K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+4K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+4K180759SECULOK™ Suture AnchorU&I Corporation20180—
+4K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+4K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+4K141385Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson201501
+4K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+4K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+4K121606Resorb-X GKLS-Martin L.P.20130—
+4K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+4K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+4K112064Resorb X-GKLS-Martin L.P.20122—
+4K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+4K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+4K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082—
+4K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+4K061507Sonicweld RX Endobrow FixationKLS-Martin L.P.20060—
+5K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+5K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+5K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+5K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+5K230733Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+5K220757Argo Knotless SP AnchorConmed Corporation20226—
+5K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC20203—
+5K193606Y-Knot OneStep AnchorConmed Corporation20200—
+5K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+5K182621CrossFT Knotless Deep Thread Suture Anchor with Disposable DriverConmed Corporation20190—
+5K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+5K171725CuffLink Implant SystemConmed Corporation20170—
+5K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20171—
+5K160500Elite SPK, Compasso, Elite SPK KitNcs Lab Srl20160—
+5K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+5K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+5K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+5K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+5K142484Sternal Closure SystemJace Medical, LLC20141—
+5K133304RXG Distraction SystemKLS-Martin L.P.20140—
+5K133224Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi SuturesConmed Corporation201412—
+5K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+5K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC20114—
+5K101484Compressyn BandDallen Medical20115—
+5K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+5K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+6K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+6K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+6K251296The Acumed Wrist Fixation SystemAcumed, LLC202501
+6K251530CONMED Argo Knotless® AnchorConmed Corporation20250—
+6K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+6K241234OTS 25-L (100-5)Ots Medical, Ltd.20251—
+6K240090Argo Knotless GENESYS AnchorConmed Corporation20242—
+6K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+6K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+6K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+6K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+6K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+6K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+6K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+6K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+6K212739ActiFlipParcus Medical, LLC20210—
+6K202663Suture WingOsteonic Co., Ltd.20211—
+6K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+6K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+6K192709Fixone All Suture AnchorAju Pharm Co., Ltd.20203—
+6K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+6K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+6K180763CuffLink Implant System BiocompositeConmed Corporation20180—
+6K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+6K171465Stryker Self-Punching ICONIXStryker20171—
+6K130431Compressyn BandDallen Medical, Inc.20134—
+6K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC20105—
+6K102162Parcus Peek CF Push-in Suture AnchorParcus Medical, LLC20100—