510(k) Report

Devices descending from K073509

64 later devices reach Twinfix PK FP Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+1K110538Pro Fixation SystemSynovis Orthopedic & Woundcare20110—
+1K093897Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div.2010292
+1K093925Lifenet SystemPhysio-Control, Inc.20108—
+1K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc.200941—
+1K083151Extremity Medical Suture AnchorExtremity Medical, LLC20091—
+2K233730Footprint Mini PK, 3.5mm Suture AnchorSmith & Nephew20240—
+2K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+2K200503ATL AnchorsInternational Life Sciences202022
+2K182264ICONN Revolution Knotless Suture AnchorIconn Orthopedics, LLC20180—
+2K173269KATOR Suture AnchorKator, LLC20182—
+2K180274Ventix Link Knotless Anchor with InserterCayenne Medical, Inc.20180—
+2K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—
+2K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company20154—
+2K150166Extremity Medical Suture AnchorExtremity Medical, LLC20150—
+2K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+2K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+2K123579Footprint Ultra PK4.5MM and 5.5MM Suture Anchor, SLSmith & Nephew, Inc.20134—
+2K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc.20126—
+2K120943Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown…ArthroCare Corporation20121—
+2K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc.201229—
+2K113274Footprint Ultra PK Suture AnchorSmith & Nephew, Inc.201216—
+2K112876Cufflink (TM) Knotless Anchor with Inserter, 4.5MM/5.5MM - Peek Only, Cufflink SP (TM)…Cayenne Medical, Inc.20117—
+2K102757Lifenet SystemPhysio-Control, Inc.20107—
+3K260317Artelon Convenience KitsInternational Life Sciences20260—
+3K253538TeKBrace Knotless AnchorTheramicro20260—
+3K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+3K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+3K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+3K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd.20210—
+3K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+3K190915OsteoFab Suture AnchorsOxford Performance Materials, Inc.20190—
+3K182507Tigon Medical Tissue AnchorsTigon Medical20192—
+3K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+3K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+3K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+3K172491ICONN Square 2.5MM Suture AnchorIconn Orthopedics, LLC20170—
+3K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+3K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+3K143392Quattro Bolt Tenodesis ScrewCayenne Medical, Inc.20150—
+3K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+3K123240Speedlock Hip Knotless Fixation ImplantArthroCare Corporation20130—
+3K121865Zoll Rescuenet 12-LeadZOLL Medical Corporation20120—
+3K111296Zoll RescuenetlinkZoll Medical Corporation, World Wide Headquarters20115—
+4K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+4K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+4K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+4K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+4K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+4K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+4K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+4K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+4K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+4K220464Tigon Medical Gryphon Anchor LineTigon Medical20231—
+4K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+4K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+4K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+4K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+4K141774Zoll X SeriesZOLL Medical Corporation20142—
+4K133484Zoll X SeriesZoll Medical Corp20141—
+5K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+5K202375ZOLL Propaq MZOLL Medical Corporation20211—
+5K142915ZOLL X SeriesZOLL Medical Corporation20140—
+6K233354WVSM Pro (Series) (500-0030-XX)Athena Gtx, Inc.20240—