Members中文

MBI

Fastener, Fixation, Nondegradable, Soft Tissue

Product code
MBI
Device name
Fastener, Fixation, Nondegradable, Soft Tissue
Device class
Class 2
21 CFR
21 CFR 888.3040
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
601

510(k) clearances, last 3 years (90)

Last three years. Most recent: 2026-08-27.

NumberDecision dateApplicantDevice name
K2626772026-08-27Riverpoint MedicalIconix Knotless T summary
K2620472026-08-03Paragon 28, Inc.Grappler Suture Anchor System summary
K2623692026-07-30Stryker EndoscopyAIR+ All-Inside Meniscal Repair Device, Curved Up;AI summary
K2617702026-07-29Skeletal Dynamics, Inc.Suture Button Repair System summary
K2616322026-07-20Responsive Arthroscopy, Inc.Thunderbolt System summary
K2619682026-07-09Smith & Nephew, Inc.Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one bl summary
K2600182026-06-26Arthrex, Inc.Arthrex FiberButton summary
K2531302026-05-27ZheJiang Decans Medical Devices Co., LDione PEEK Screw System summary
K2613632026-05-13CONMED CorporationY-Knotless™ Flex Anchors summary
K2530272026-05-06Ortobio S.A.Anchor with Fiber Wire and Disposable Inserter summary
K2526352026-05-01ArthroTAK, LLCArthroTAK Tendon Anchor Kit summary
K2609212026-04-21Tigon MedicalTigon Medical Static Javelin All-Suture Anchors & Ja summary
K2605612026-03-20Arthrex, Inc.Arthrex FiberTak Suture Anchor summary
K2538862026-03-17Paragon 28, Inc.Grappler Suture Anchor PCFD Tether System summary
K2541762026-03-16BAAT Medical Products B.V.SINEFIX summary
K2517502026-03-12Trax Surgical, Inc.Trax EX Anchor summary
K2536932026-03-11Riverpoint Medical, LLCStrut Suture; No-Tie Button summary
K2604052026-03-09Arthrex, Inc.FiberTape Button summary
K2535382026-03-06TheramicroTeKBrace Knotless Anchor summary
K2543062026-03-04Aevumed, Inc.Aevumed FENIX Suture Anchor summary
K2542292026-03-02Arthrex, Inc.Arthrex Nano FiberTak Suture Anchor summary
K2536952026-02-27Riverpoint Medical, LLCLigaMend summary
K2537632026-01-29Conmed CorporationY-Knotless™ Flex Anchors summary
K2600042026-01-28Aevumed, Inc.Aevumed PROTEKT Suture Anchor summary
K2536182026-01-06Abanza Tecnomed S.LQuadLock™ Fixation System summary
K2538952025-12-30Arthrex, Inc.Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm summary
K2525962025-12-04Tigon MedicalTigon Medical Knotless and Dual Javelin All-Suture A summary
K2526642025-11-04GM Dos Reis Industria e Comercio Ltda.GMReis Suture Anchors summary
K2523142025-10-29Arthrex, Inc.Arthrex SutureTak Suture Anchor summary
K2530402025-10-21Aevumed, Inc.Aevumed FASE Suture Anchor summary
K2530102025-10-14Responsive Arthroscopy, LLCMini Superhawk Suture Anchor System summary
K2500952025-09-05Suturetech, Inc.All-Suture Dual Anchor System summary
K2428952025-08-06Aevumed, Inc.Aevumed PHANTOM Suture Anchors summary
K2521442025-07-30Riverpoint MedicalIconix Speed Anchor; Iconix Speed HA+ Anchor summary
K2513102025-07-22Ots Medical , Ltd.OTS 25-L (100-5) summary
K2518092025-07-18Arthrex, Inc.Arthrex FiberTak Suture Anchor summary
K2511452025-07-10Arthrex, Inc.Arthrex PushLock Suture Anchors summary
K2519332025-07-01Medacta International S.A.SnugFit ASA Extension summary
K2516272025-06-25Smith & Nephew, Inc.BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Su summary
K2515302025-06-18Conmed CorporationCONMED Argo Knotless® Anchor summary
K2508442025-06-02Science & Bio Materials (S.B.M.) SasPULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; R summary
K2424772025-05-12Signature Orthopaedics Pty, Ltd.Shoulder Soft Tissue Anchors summary
K2505962025-03-28Arthrex, Inc.Arthrex FiberTak Suture Anchor summary
K2439882025-03-20Riverpoint Medical, LLCRootMend MRR summary
K2504242025-03-11Arthrex, Inc.Arthrex TightRope Soft Button, RT summary
K2502382025-02-25Abanza Tecnomed S.LWasherCap™ Fixation System summary
K2440152025-02-19Arcuro Medical , Ltd.SuperBall-RC™ summary
K2436652025-01-31ZheJiang Decans Medical Devices Co., LCrius PEEK Suture Anchor System (Thread-Fix Anchor); summary
K2437122025-01-30Abanza Tecnomed S.LWasherCap™ Mini Fixation System (Model 45) summary
K2437262025-01-30Responsive Arthroscopy, Inc.Osprey Suture Anchor summary
K2440252025-01-28Conmed CorporationArgo Knotless GENESYS Anchor summary
K2412342025-01-23Ots Medical , Ltd.OTS 25-L (100-5) summary
K2425292024-12-20Tigon MedicalTigon Medical All-Suture Anchors (ASA) summary
K2434702024-12-03Osteonic Co., Ltd.Fix2Lock (PEEK Self Punching) summary
K2424942024-11-26Riverpoint Medical, LLCOsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Co summary
K2433232024-11-19Riverpoint MedicalIconix Knotless Anchor summary
K2432032024-10-29Riverpoint MedicalOC JuggerKnotless Soft Anchor; OC JuggerLoop Soft An summary
K2416952024-09-12Field OrthopaedicsExtremity All Suture System summary
K2422962024-08-29Ortho-Design (Pty), Ltd.VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture summary
K2336012024-08-02Aju Pharm Co., Ltd.Fixone Meniscal Repair summary
K2418642024-07-25Paragon 28, Inc.Grappler Interference Screw System summary
K2408352024-07-19Skeletal Dynamics, Inc.Suture Button Repair System summary
K2415772024-07-03Riverpoint MedicalIconix® Anchor summary
K2414352024-06-20Smith & Nephew, Inc.Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one U summary
K2412352024-05-29Arthrex, Inc.Arthrex TightRope II summary
K2329412024-05-03Suzhou Endophix Co., Ltd.Megaloop Button System summary
K2407192024-04-11Riverpoint MedicalOC JuggerKnot Soft Anchor summary
K2405942024-03-26Paragon 28, Inc.Grappler Suture Anchor R3FLEX IOL System summary
K2404072024-03-07Stryker EndoscopyICONIX All-Suture Anchor; ICONIX TT All-Suture Ancho summary
K2402132024-02-23Riverpoint MedicalIconix Knotless Anchor summary
K2401942024-02-21Riverpoint MedicalProCinch, QuadCinch summary
K2338932024-01-25Stryker EndoscopyAlphaVent Knotless SP PEEK Anchor summary
K2337302024-01-17Smith & NephewFootprint Mini PK, 3.5mm Suture Anchor summary
K2310332024-01-04Healthium Medtech LimitedCEPTRE® Knotted UHMWPE Suture PEEK Anchor summary
K2308912023-12-28Healthium Medtech LimitedSURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repai summary
K2336592023-12-26Osteonic Co., Ltd.Suture Wing summary
K2334292023-12-07Ots Medical , Ltd.OTS 25 (100-1) summary
K2335522023-11-30Riverpoint MedicalIDEAL Ziploop summary
K2329732023-11-15Arthrex, Inc.Arthrex Knee FiberTak® Button Suture Anchor summary
K2334682023-11-14Riverpoint MedicalIconix Anchor summary
K2328862023-11-08Healthium Medtech LimitedINFILOOP® Fixed Loop UHMWPE Suture Titanium Button summary
K2327422023-11-03Arthrex, Inc.Arthrex FiberTak Suture Anchor summary
K2327252023-11-02Suzhou Endophix Co., Ltd.Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor summary
K2326832023-10-24Stryker EndoscopyKnotilus+ PEEK Knotless Anchor summary
K2332582023-10-23Responsive Arthroscopy, LLCShadow Knotless All-Suture Anchors summary
K2324922023-10-06Medos International SARL2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GR summary
K2324112023-10-06Riverpoint Medical, LLCJuggerKnot Soft Anchor OC summary
K2310782023-10-05Riverpoint Medical, LLCAll-Suture Anchor summary
K2325922023-09-20Acuitive Technologies, Inc.CITRELOCK® DUO summary
K2305172023-09-11Jarmon Medical, LLC (Dba Legends OrthoLegends Orthopedics Suture Anchors (Legends Orthoped summary
Official FDA classification page: MBI
Classification and pathway per current FDA publications. Data from openFDA (CC0).