510(k) Report

Devices descending from K972326

488 later devices reach Peba Anchor/Suture Combination through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K081893Opus Magnum Speedscrew Knotless Fixation Device, Model OM-6500Arthrocare Corp.200816—
+3K0815112.0 PK Suture Anchor T, 2.0 PK Suture Anchor SSmith & Nephew, Inc.20083—
+3K072291Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec200825—
+3K071586Bioraptor 2.3 PK Suture AnchorSmith & Nephew Inc., Endoscopy Division20071211
+3K070882Stryker Peek Twinloop TacStryker Endoscopy200735—
+3K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.200710—
+3K071177Arthrex Bio- Composite Suture Anchors: Bio-Composite Pushlock, Bio-Composite Tak…Arthrex, Inc.2007227—
+3K070908Smith & Nephew Kinsa RC Suture AnchorSmith & Nephew Inc., Endoscopy Division200760—
+3K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation200601
+3K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation20041—
+4K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC20260—
+4K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.20260—
+4K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.20260—
+4K262047Grappler Suture Anchor SystemParagon 28, Inc.20260—
+4K260018Arthrex FiberButtonArthrex, Inc.20260—
+4K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+4K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+4K253538TeKBrace Knotless AnchorTheramicro20260—
+4K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda.20251—
+4K250544Knotilus+ Biocomposite Knotless AnchorStryker Endoscopy20250—
+4K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+4K241695Extremity All Suture SystemField Orthopaedics20240—
+4K241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsDepuy Mitek20240—
+4K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+4K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20241—
+4K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+4K233730Footprint Mini PK, 3.5mm Suture AnchorSmith & Nephew20240—
+4K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited20240—
+4K233429OTS 25 (100-1)Ots Medical, Ltd.20232—
+4K232683Knotilus+ PEEK Knotless AnchorStryker Endoscopy20232—
+4K233258Shadow Knotless All-Suture AnchorsResponsive Arthroscopy, LLC20230—
+4K2324922.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite…Medos International SARL20230—
+4K232340Arthrex 2.4mm Knotless Hip SutureTak® Suture AnchorArthrex, Inc.20230—
+4K231867Grappler Suture Anchor SystemParagon 28, Inc.20230—
+4K231376Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)Smith & Nephew, Inc.20230—
+4K220464Tigon Medical Gryphon Anchor LineTigon Medical20231—
+4K223878Aevumed RAPID Suture AnchorsAevumed, Inc.20236—
+4K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc.20232—
+4K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+4K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+4K222091Grappler Suture Anchor SystemParagon 28, Inc.20223—
+4K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+4K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K221099Arthrex Self-Punching PushLock Suture AnchorArthrex, Inc.20225—
+4K220797FootHold SystemCrossroads Extremity Systems, LLC20220—
+4K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+4K210122Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)Osteonic Co., Ltd.20210—
+4K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+4K202763Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20212—
+4K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+4K203493MectaLock ExtensionMedacta International S.A.20210—
+4K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+4K201636Hercules Suture Anchor SystemIn2bones USA, LLC20201—
+4K2018836.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite AnchorMedos International SARL20201—
+4K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+4K192032Fixone Biocomposite Small AnchorAju Pharm Co., Ltd.20204—
+4K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+4K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+4K192532Arthrex SwiveLock AnchorArthrex, Inc.201916—
+4K190446Responsive Arthroscopy Wedge Push-In Suture AnchorsResponsive Arthroscopy, LLC20191—
+4K182898TenoTac Soft Tissue Fixation SystemParagon 28, Inc.20191—
+4K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+4K181746MICRORAPTOR Knotless Suture AnchorSmith and Nephew, Inc.20183—
+4K181769Arthrex FiberTak Suture AnchorArthrex, Inc.201824—
+4K180759SECULOK™ Suture AnchorU&I Corporation20180—
+4K180594Knotless SutureTak AnchorsArthrex, Inc.20181—
+4K173269KATOR Suture AnchorKator, LLC20182—
+4K180118Arthrex NanoSuture AnchorArthrex, Inc.201821
+4K173240Arthrex PushLockArthrex, Inc.20182—
+4K171964LigaMetrics Suture AnchorsMortise Medical, LLC20170—
+4K171299Fixone Biocomposite AnchorAju Pharm Co., Ltd.20174—
+4K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc.20172—
+4K163672Nanova Screw-In Suture Anchor, Nanova Push-In Suture AnchorNanova Biomaterials, Inc.20170—
+4K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL20162—
+4K160118STROPP (Single Tunnel Repair of Plantar Plate)Crossroads Extremity Systems, LLC20160—
+4K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+4K151092Arthrex Short Suture AnchorsArthrex, Inc.201612—
+4K153395OS2-C Compression StapleIn2bones Sas20167—
+4K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+4K152255BoneCam Suture AnchorsValeris Medical20151—
+4K143582Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, SteelResorba Medical GmbH20150—
+4K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+4K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture…Arthrex, Inc.20154—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K1507152.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture AnchorsTornier, Inc.20152—
+4K143092Tensyn PlugDallen Medical, Inc.20151—
+4K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+4K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140—
+4K140476Arthrex Fibertak Suture AnchorArthrex, Inc.201429—
+4K141219Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsBiomet Manufacturing Corp20141—
+4K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+4K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+4K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+4K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+4K140925Acumed Suture Anchor SystemAcumed, LLC20140—
+4K133777Tornier Insite (TM) FT Peek Knotless Suture AnchorTornier, Inc.20140—
+4K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+4K133858Tensyn BandDallen Medical, Inc.20143—
+4K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—