MBI
- 产品代码
- MBI
- 器械名称
- Fastener, Fixation, Nondegradable, Soft Tissue
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3040
- FDA 专业组
- Orthopedic
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 该代码近三年的 510(k)
- 601 件
该代码近三年的 510(k)（90 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K262677 | 2026-08-27 | Riverpoint Medical | Iconix Knotless T 摘要 |
| K262047 | 2026-08-03 | Paragon 28, Inc. | Grappler Suture Anchor System 摘要 |
| K262369 | 2026-07-30 | Stryker Endoscopy | AIR+ All-Inside Meniscal Repair Device, Curved Up;AI 摘要 |
| K261770 | 2026-07-29 | Skeletal Dynamics, Inc. | Suture Button Repair System 摘要 |
| K261632 | 2026-07-20 | Responsive Arthroscopy, Inc. | Thunderbolt System 摘要 |
| K261968 | 2026-07-09 | Smith & Nephew, Inc. | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one bl 摘要 |
| K260018 | 2026-06-26 | Arthrex, Inc. | Arthrex FiberButton 摘要 |
| K253130 | 2026-05-27 | ZheJiang Decans Medical Devices Co., L | Dione PEEK Screw System 摘要 |
| K261363 | 2026-05-13 | CONMED Corporation | Y-Knotless Flex Anchors 摘要 |
| K253027 | 2026-05-06 | Ortobio S.A. | Anchor with Fiber Wire and Disposable Inserter 摘要 |
| K252635 | 2026-05-01 | ArthroTAK, LLC | ArthroTAK Tendon Anchor Kit 摘要 |
| K260921 | 2026-04-21 | Tigon Medical | Tigon Medical Static Javelin All-Suture Anchors & Ja 摘要 |
| K260561 | 2026-03-20 | Arthrex, Inc. | Arthrex FiberTak Suture Anchor 摘要 |
| K253886 | 2026-03-17 | Paragon 28, Inc. | Grappler Suture Anchor PCFD Tether System 摘要 |
| K254176 | 2026-03-16 | BAAT Medical Products B.V. | SINEFIX 摘要 |
| K251750 | 2026-03-12 | Trax Surgical, Inc. | Trax EX Anchor 摘要 |
| K253693 | 2026-03-11 | Riverpoint Medical, LLC | Strut Suture; No-Tie Button 摘要 |
| K260405 | 2026-03-09 | Arthrex, Inc. | FiberTape Button 摘要 |
| K253538 | 2026-03-06 | Theramicro | TeKBrace Knotless Anchor 摘要 |
| K254306 | 2026-03-04 | Aevumed, Inc. | Aevumed FENIX Suture Anchor 摘要 |
| K254229 | 2026-03-02 | Arthrex, Inc. | Arthrex Nano FiberTak Suture Anchor 摘要 |
| K253695 | 2026-02-27 | Riverpoint Medical, LLC | LigaMend 摘要 |
| K253763 | 2026-01-29 | Conmed Corporation | Y-Knotless Flex Anchors 摘要 |
| K260004 | 2026-01-28 | Aevumed, Inc. | Aevumed PROTEKT Suture Anchor 摘要 |
| K253618 | 2026-01-06 | Abanza Tecnomed S.L | QuadLock Fixation System 摘要 |
| K253895 | 2025-12-30 | Arthrex, Inc. | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm 摘要 |
| K252596 | 2025-12-04 | Tigon Medical | Tigon Medical Knotless and Dual Javelin All-Suture A 摘要 |
| K252664 | 2025-11-04 | GM Dos Reis Industria e Comercio Ltda. | GMReis Suture Anchors 摘要 |
| K252314 | 2025-10-29 | Arthrex, Inc. | Arthrex SutureTak Suture Anchor 摘要 |
| K253040 | 2025-10-21 | Aevumed, Inc. | Aevumed FASE Suture Anchor 摘要 |
| K253010 | 2025-10-14 | Responsive Arthroscopy, LLC | Mini Superhawk Suture Anchor System 摘要 |
| K250095 | 2025-09-05 | Suturetech, Inc. | All-Suture Dual Anchor System 摘要 |
| K242895 | 2025-08-06 | Aevumed, Inc. | Aevumed PHANTOM Suture Anchors 摘要 |
| K252144 | 2025-07-30 | Riverpoint Medical | Iconix Speed Anchor; Iconix Speed HA+ Anchor 摘要 |
| K251310 | 2025-07-22 | Ots Medical , Ltd. | OTS 25-L (100-5) 摘要 |
| K251809 | 2025-07-18 | Arthrex, Inc. | Arthrex FiberTak Suture Anchor 摘要 |
| K251145 | 2025-07-10 | Arthrex, Inc. | Arthrex PushLock Suture Anchors 摘要 |
| K251933 | 2025-07-01 | Medacta International S.A. | SnugFit ASA Extension 摘要 |
| K251627 | 2025-06-25 | Smith & Nephew, Inc. | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Su 摘要 |
| K251530 | 2025-06-18 | Conmed Corporation | CONMED Argo Knotless® Anchor 摘要 |
| K250844 | 2025-06-02 | Science & Bio Materials (S.B.M.) Sas | PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; R 摘要 |
| K242477 | 2025-05-12 | Signature Orthopaedics Pty, Ltd. | Shoulder Soft Tissue Anchors 摘要 |
| K250596 | 2025-03-28 | Arthrex, Inc. | Arthrex FiberTak Suture Anchor 摘要 |
| K243988 | 2025-03-20 | Riverpoint Medical, LLC | RootMend MRR 摘要 |
| K250424 | 2025-03-11 | Arthrex, Inc. | Arthrex TightRope Soft Button, RT 摘要 |
| K250238 | 2025-02-25 | Abanza Tecnomed S.L | WasherCap Fixation System 摘要 |
| K244015 | 2025-02-19 | Arcuro Medical , Ltd. | SuperBall-RC 摘要 |
| K243665 | 2025-01-31 | ZheJiang Decans Medical Devices Co., L | Crius PEEK Suture Anchor System (Thread-Fix Anchor); 摘要 |
| K243712 | 2025-01-30 | Abanza Tecnomed S.L | WasherCap Mini Fixation System (Model 45) 摘要 |
| K243726 | 2025-01-30 | Responsive Arthroscopy, Inc. | Osprey Suture Anchor 摘要 |
| K244025 | 2025-01-28 | Conmed Corporation | Argo Knotless GENESYS Anchor 摘要 |
| K241234 | 2025-01-23 | Ots Medical , Ltd. | OTS 25-L (100-5) 摘要 |
| K242529 | 2024-12-20 | Tigon Medical | Tigon Medical All-Suture Anchors (ASA) 摘要 |
| K243470 | 2024-12-03 | Osteonic Co., Ltd. | Fix2Lock (PEEK Self Punching) 摘要 |
| K242494 | 2024-11-26 | Riverpoint Medical, LLC | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Co 摘要 |
| K243323 | 2024-11-19 | Riverpoint Medical | Iconix Knotless Anchor 摘要 |
| K243203 | 2024-10-29 | Riverpoint Medical | OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft An 摘要 |
| K241695 | 2024-09-12 | Field Orthopaedics | Extremity All Suture System 摘要 |
| K242296 | 2024-08-29 | Ortho-Design (Pty), Ltd. | VersaTap Suture Anchor (ADP050); VersaPEEK Suture 摘要 |
| K233601 | 2024-08-02 | Aju Pharm Co., Ltd. | Fixone Meniscal Repair 摘要 |
| K241864 | 2024-07-25 | Paragon 28, Inc. | Grappler Interference Screw System 摘要 |
| K240835 | 2024-07-19 | Skeletal Dynamics, Inc. | Suture Button Repair System 摘要 |
| K241577 | 2024-07-03 | Riverpoint Medical | Iconix® Anchor 摘要 |
| K241435 | 2024-06-20 | Smith & Nephew, Inc. | Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one U 摘要 |
| K241235 | 2024-05-29 | Arthrex, Inc. | Arthrex TightRope II 摘要 |
| K232941 | 2024-05-03 | Suzhou Endophix Co., Ltd. | Megaloop Button System 摘要 |
| K240719 | 2024-04-11 | Riverpoint Medical | OC JuggerKnot Soft Anchor 摘要 |
| K240594 | 2024-03-26 | Paragon 28, Inc. | Grappler Suture Anchor R3FLEX IOL System 摘要 |
| K240407 | 2024-03-07 | Stryker Endoscopy | ICONIX All-Suture Anchor; ICONIX TT All-Suture Ancho 摘要 |
| K240213 | 2024-02-23 | Riverpoint Medical | Iconix Knotless Anchor 摘要 |
| K240194 | 2024-02-21 | Riverpoint Medical | ProCinch, QuadCinch 摘要 |
| K233893 | 2024-01-25 | Stryker Endoscopy | AlphaVent Knotless SP PEEK Anchor 摘要 |
| K233730 | 2024-01-17 | Smith & Nephew | Footprint Mini PK, 3.5mm Suture Anchor 摘要 |
| K231033 | 2024-01-04 | Healthium Medtech Limited | CEPTRE® Knotted UHMWPE Suture PEEK Anchor 摘要 |
| K230891 | 2023-12-28 | Healthium Medtech Limited | SURESTITCH UHMWPE Suture PEEK Button Meniscus Repai 摘要 |
| K233659 | 2023-12-26 | Osteonic Co., Ltd. | Suture Wing 摘要 |
| K233429 | 2023-12-07 | Ots Medical , Ltd. | OTS 25 (100-1) 摘要 |
| K233552 | 2023-11-30 | Riverpoint Medical | IDEAL Ziploop 摘要 |
| K232973 | 2023-11-15 | Arthrex, Inc. | Arthrex Knee FiberTak® Button Suture Anchor 摘要 |
| K233468 | 2023-11-14 | Riverpoint Medical | Iconix Anchor 摘要 |
| K232886 | 2023-11-08 | Healthium Medtech Limited | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button 摘要 |
| K232742 | 2023-11-03 | Arthrex, Inc. | Arthrex FiberTak Suture Anchor 摘要 |
| K232725 | 2023-11-02 | Suzhou Endophix Co., Ltd. | Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor 摘要 |
| K232683 | 2023-10-24 | Stryker Endoscopy | Knotilus+ PEEK Knotless Anchor 摘要 |
| K233258 | 2023-10-23 | Responsive Arthroscopy, LLC | Shadow Knotless All-Suture Anchors 摘要 |
| K232492 | 2023-10-06 | Medos International SARL | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GR 摘要 |
| K232411 | 2023-10-06 | Riverpoint Medical, LLC | JuggerKnot Soft Anchor OC 摘要 |
| K231078 | 2023-10-05 | Riverpoint Medical, LLC | All-Suture Anchor 摘要 |
| K232592 | 2023-09-20 | Acuitive Technologies, Inc. | CITRELOCK® DUO 摘要 |
| K230517 | 2023-09-11 | Jarmon Medical, LLC (Dba Legends Ortho | Legends Orthopedics Suture Anchors (Legends Orthoped 摘要 |
FDA 官方分类页： MBI
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。