510(k) Report

Devices descending from K990987

215 later devices reach Bio-Absorbable Corkscrew, Model AR-1920B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043337Arthrex Bio-Corkscrew FT Suture AnchorArthrex, Inc.2004145—
+1K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd.200377—
+1K023192Stryker Biozip Suture AnchorStryker Endoscopy20034—
+1K020056Duet Suture AnchorBionx Implants, Ltd.200278—
+2K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+2K070882Stryker Peek Twinloop TacStryker Endoscopy200735—
+2K070758Stryker Peek Zip Suture AnchorStryker Endoscopy20072—
+2K061949Doubleplay Suture AnchorBiocomposites, Ltd.20060—
+2K061665Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FTArthrex, Inc.2006114—
+2K053561Bio-Mini Revo Suture AnchorConmed Linvatec200675—
+2K042966Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218…Linvatec Biomaterials, Ltd.200476—
+2K041305Stryker Biozip Suture Anchor SystemStryker Endoscopy20043—
+3K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+3K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+3K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+3K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+3K181680ICONN Answer II Suture AnchorIconn Orthopedics, LLC20180—
+3K180759SECULOK™ Suture AnchorU&I Corporation20180—
+3K180464AEVUMED PHANTOM Suture AnchorsAevumed, Inc.20184—
+3K173788Arthrex Corkscrew FTArthrex, Inc.20185—
+3K152236KATOR Suture AnchorKator, LLC20154—
+3K142643Stabilynx PEEK Suture AnchorD3 Dc, LLC /Stabilynx, Inc.20140—
+3K120509Stryker All Suture AnchorsStryker201227—
+3K113274Footprint Ultra PK Suture AnchorSmith & Nephew, Inc.201216—
+3K113297Knotilus Anchor SystemT.A.G. Medical Products Corporation, Ltd.20123—
+3K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+3K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC201149—
+3K111779Y-Knot All-Suture Anchor Model HF13Conmed Linvatec201129—
+3K110538Pro Fixation SystemSynovis Orthopedic & Woundcare20110—
+3K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec201052
+3K092133Arthrocare Titanium Suture Anchor, Model 22-9055,22-9055N, 22-9065, 22-9065NArthrocare Corp.20095—
+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—
+3K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+3K080335Tornier Cinch Knotless Fixation Implant SystemTornier, Inc.20087—
+3K071157Stryker Peek and Titanium Soft Eyelet AnchorsStryker Endoscopy2007125
+4K261363Y-Knotless™ Flex AnchorsCONMED Corporation20260—
+4K254306Aevumed FENIX Suture AnchorAevumed, Inc.20260—
+4K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.20262—
+4K250095All-Suture Dual Anchor SystemSuturetech, Inc.20250—
+4K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+4K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorArthrex, Inc.20250—
+4K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+4K220966SinefixBAAT Medical Products B.V.20231—
+4K222589Flexible Suturing System with Anchors (FSSA)Integrity Orthopaedics, Inc.20230—
+4K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+4K203523Fixone hybrid knotless anchorAju Pharm Co., Ltd.202118
+4K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…B-One Ortho, Corp.20210—
+4K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+4K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+4K202178VersaLoop Anchor SystemT.A.G. Medical Products Corporation, Ltd.20200—
+4K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+4K192984APTUS Clavicle SystemMedartis AG20206—
+4K193157Arthrex 3.9mm Corkscrew Suture AnchorArthrex, Inc.20191—
+4K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+4K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+4K1811202.8 mm/3.3 mm PopLok Suture AnchorsConmed Corporation20180—
+4K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+4K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+4K173269KATOR Suture AnchorKator, LLC20182—
+4K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—
+4K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation20172—
+4K163258CrossFT Knotless Suture Anchor with Disposable DriverConmed Corporation20179—
+4K162386KATOR Suture AnchorKator, LLC20163—
+4K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+4K151201Stryker ICONIX with NeedlesStryker201510—
+4K133671Iconix All Suture AnchorsStryker Corp.201425—
+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—
+4K123579Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSmith & Nephew, Inc.20134—
+4K120356NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl20121—
+4K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+4K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+4K112965Nano Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec201196
+4K111397Titan TI Suture Anchor SystemArthrocare Corp.20110—
+4K102262Arthocare Spartan Peek Suture Implant System; Punch Tap ; Extraction ToolArthrocare Corp.20102—
+4K101184Titan TI Suture Anchor System, Models 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022…Arthrocare Corp.20104—
+4K091870Tornier, Piton Fixation Implant SystemTornier20096—
+4K090075Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC200913—
+4K080447Surgicraft Screw Fixation SystemSurgicraft, Ltd.20080—
+5K260018Arthrex FiberButtonArthrex, Inc.20260—
+5K260761APTUS Clavicle System 2.8Medartis AG20260—
+5K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC20261—
+5K254176SinefixBAAT Medical Products B.V.20260—
+5K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+5K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+5K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+5K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+5K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+5K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+5K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+5K231278Knotless Suture AnchorRiverpoint Medical, LLC202331
+5K230892Fixone Biocomposite AnchorAju Pharm Co., Ltd.202308
+5K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+5K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+5K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—