510(k) Report

Devices descending from K121018

29 later devices reach Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture an through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+1K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+1K182507Tigon Medical Tissue AnchorsTigon Medical20192—
+1K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+1K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+1K172491ICONN Square 2.5MM Suture AnchorIconn Orthopedics, LLC20170—
+1K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+1K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company20154—
+1K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+2K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+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—
+2K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+2K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+2K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+2K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+2K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+2K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+2K220464Tigon Medical Gryphon Anchor LineTigon Medical20231—
+2K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+2K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+2K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd.20210—
+2K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+2K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+2K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+2K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+3K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+3K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—