510(k) Report

Devices descending from K082215

46 later devices reach Osteoraptor Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+1K180361MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc.20184—
+1K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC20161—
+1K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+1K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc.201229—
+1K103309Osteoraptor Curved 2.3 Suture AnchorsSmith & Nephew Endoscopy, Inc.20112—
+1K101459Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766…Smith & Nephew, Inc.201110—
+1K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc.20101611
+2K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+2K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+2K182507Tigon Medical Tissue AnchorsTigon Medical20192—
+2K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+2K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+2K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc.20183—
+2K172491ICONN Square 2.5MM Suture AnchorIconn Orthopedics, LLC20170—
+2K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—
+2K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+2K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company20154—
+2K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+2K123393Healicoil Suture Anchor with RegenesorbSmith & Nephew, Inc.20134—
+2K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+3K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+3K252314Arthrex SutureTak Suture AnchorArthrex, Inc.20250—
+3K251809Arthrex FiberTak Suture AnchorArthrex, Inc.20251—
+3K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+3K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+3K243665Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…ZheJiang Decans Medical Devices Co., Ltd.20250—
+3K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+3K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+3K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+3K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+3K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+3K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+3K220464Tigon Medical Gryphon Anchor LineTigon Medical20231—
+3K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+3K213104Auxilock Titanium Screw-In Suture AnchorAuxein Medical Private Limited20220—
+3K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd.20210—
+3K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+3K193558HEALICOIL Knotless Suture AnchorsSmith & Nephew, Inc.20200—
+3K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+3K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+3K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+3K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+4K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+4K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+4K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—