510(k) Report

Devices descending from K071586

121 later devices reach Bioraptor 2.3 PK Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233730Footprint Mini PK, 3.5mm Suture AnchorSmith & Nephew20240—
+1K231376Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)Smith & Nephew, Inc.20230—
+1K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc.20183—
+1K153395OS2-C Compression StapleIn2bones Sas20167—
+1K151105Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew…Smith & Nephew, Inc.2015140
+1K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+1K132461A.I.M. Suture AnchorAnchor Innovation Medical, Inc.20130—
+1K131769Cinchlock Knotless Suture Anchor, Nanotack Suture Anchor 1.4MMPivot Medical, Inc.2013122
+1K131325Quattro GL Suture AnchorCayenne Medical, Inc.20130—
+1K121356Micro/Mini N-PK (H) Bone AnchorAnulex Technologies, Inc.20120—
+1K121354Micro/Mini N-PK (F) Bone AnchorAnulex Technologies, Inc.20120—
+1K120943Speedlock Hip Knotless Fixation Implant Speedlock Hip Drill Speedlock Hip Guide Crown…ArthroCare Corporation20121—
+1K121018Bioraptor 2.9, Bioraptor 2.3 PK, Osteoraptor, & Bioraptor Knotless Suture anSmith & Nephew, Inc.201229—
+1K112960Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe…Cayenne Medical, Inc.20121—
+1K110773Tornier Insite FT Suture AnchorTornier, Inc.20115—
+1K110473Nanotack Suture Anchor 1.4MMPivot Medical20112—
+1K103262Quickdraw Convertible Fixation Implant SystemTornier, Inc.20110—
+1K102660Bioraptor Curved 2.3 PK Suture AnchorsSmith & Nephew Endoscopy, Inc.20108—
+1K093428Smith & Nephew Knotless Instability AnchorSmith & Nephew Endoscopy, Inc.200941—
+1K083635Smith & Nephew Biosure PK Interference ScrewSmith & Nephew Endoscopy, Inc.200921—
+1K083226Smith & Nephew Peek Interference ScrewSmith & Nephew Endoscopy, Inc.20099—
+1K082215Osteoraptor Suture AnchorSmith & Nephew Inc., Endoscopy Division2008469
+1K0815112.0 PK Suture Anchor T, 2.0 PK Suture Anchor SSmith & Nephew, Inc.20083—
+2K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K252314Arthrex SutureTak Suture AnchorArthrex, Inc.20250—
+2K251809Arthrex FiberTak Suture AnchorArthrex, Inc.20251—
+2K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+2K230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw SheathSuzhou Endophix Co., Ltd.20230—
+2K230655PEEK RCI Screw; Bio-Composite Screw; SignaLoc ScrewSignature Orthopaedics Pty, Ltd.20230—
+2K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+2K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+2K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+2K202883Sterile bone screw (PEEK ACL screw)Osteonic Co., Ltd.20200—
+2K200503ATL AnchorsInternational Life Sciences202022
+2K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+2K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+2K190892MectaScrew PEEK Interference ScrewMedacta International S.A.20191—
+2K182507Tigon Medical Tissue AnchorsTigon Medical20192—
+2K181076Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20192—
+2K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+2K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20182—
+2K180361MICRORAPTOR REGENESORB Suture AnchorSmith and Nephew, Inc.20184—
+2K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+2K172491ICONN Square 2.5MM Suture AnchorIconn Orthopedics, LLC20170—
+2K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—
+2K163440Stealth Staple SystemFirst Ray, LLC20173—
+2K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.20160—
+2K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC20161—
+2K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+2K151220Dunamis Interference ScrewDunamis, LLC20150—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+2K151314CinchLock Flex Knotless Suture AnchorPivot Medical201502
+2K143660Milagro / Milagro Advance Interference ScrewDepuy Mitek, A Johnson & Johnson Company20154—
+2K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc.20141—
+2K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+2K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.201471
+2K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+2K132632Tornier Insite FT Suture Anchor with NeedlesTornier, Inc.20130—
+2K130351Nanotack Suture Anchor 1.4MM with Flex InserterPivot Medical, Inc.20130—
+2K123651Cinchlock Knotless Suture AnchorPivot Medical20130—
+2K123240Speedlock Hip Knotless Fixation ImplantArthroCare Corporation20130—
+2K122596Arthroscopic Surgical Instruments - Interference Screw SystemsSmith & Nephew, Inc.20120—
+2K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc.20126—
+2K113591Cols PeekFournitures Hospitalieres Industrie20110—
+2K103309Osteoraptor Curved 2.3 Suture AnchorsSmith & Nephew Endoscopy, Inc.20112—
+2K101459Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766…Smith & Nephew, Inc.201110—
+2K093844Smith & Nephew Twinfix Ultra HA Suture AnchorSmith & Nephew, Inc.20101611
+2K093943Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div.20101—
+2K091093Parcus Ppek CF Interference ScrewParcus Medical, LLC20094—
+3K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+3K260317Artelon Convenience KitsInternational Life Sciences20260—
+3K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+3K253538TeKBrace Knotless AnchorTheramicro20260—
+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—
+3K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+3K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+3K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+3K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+3K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorSuzhou Endophix Co., Ltd.20230—
+3K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+3K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+3K232005HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor…Smith & Nephew, Inc.20230—
+3K230123Apollo Knotless Suture AnchorMaruho Medical20230—
+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—
+3K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+3K203335MectaScrew ExtensionMedacta International S.A.20220—
+3K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd.20210—
+3K210498Betta Link Knotless Implant SystemT.A.G. Medical Products Corporation, Ltd.202101
+3K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc.20200—
+3K202569Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20200—
+3K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+3K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+3K190915OsteoFab Suture AnchorsOxford Performance Materials, Inc.20190—