Product code MBI
- Device name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3040
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261869 | Integrity Retractable Implant Inserter (6000127) | Anika Therapeutics, Inc. | 2026-09-17 |
| K253065 | Aevumed SUPERCYNCH™ Button System | Aevumed, Inc. | 2026-09-02 |
| K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026-09-02 |
| K262677 | Iconix Knotless T | Riverpoint Medical | 2026-08-27 |
| K262047 | Grappler Suture Anchor System | Paragon 28, Inc. | 2026-08-03 |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down | Stryker Endoscopy | 2026-07-30 |
| K261770 | Suture Button Repair System | Skeletal Dynamics, Inc. | 2026-07-29 |
| K261632 | Thunderbolt System | Responsive Arthroscopy, Inc. | 2026-07-20 |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) | Smith & Nephew, Inc. | 2026-07-09 |
| K260018 | Arthrex FiberButton | Arthrex, Inc. | 2026-06-26 |
| K253130 | Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-27 |
| K261363 | Y-Knotless™ Flex Anchors | CONMED Corporation | 2026-05-13 |
| K253027 | Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. | 2026-05-06 |
| K252635 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | 2026-05-01 |
| K260921 | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | Tigon Medical | 2026-04-21 |
| K260561 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-20 |
| K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | 2026-03-17 |
| K254176 | SINEFIX | BAAT Medical Products B.V. | 2026-03-16 |
| K251750 | Trax EX Anchor | Trax Surgical, Inc. | 2026-03-12 |
| K253693 | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | 2026-03-11 |
| K260405 | FiberTape Button | Arthrex, Inc. | 2026-03-09 |
| K253538 | TeKBrace Knotless Anchor | Theramicro | 2026-03-06 |
| K254306 | Aevumed FENIX Suture Anchor | Aevumed, Inc. | 2026-03-04 |
| K254229 | Arthrex Nano FiberTak Suture Anchor | Arthrex, Inc. | 2026-03-02 |
| K253695 | LigaMend | Riverpoint Medical, LLC | 2026-02-27 |
| K253763 | Y-Knotless™ Flex Anchors | Conmed Corporation | 2026-01-29 |
| K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | 2026-01-28 |
| K253618 | QuadLock™ Fixation System | Abanza Tecnomed S.L | 2026-01-06 |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | Arthrex, Inc. | 2025-12-30 |
| K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical | 2025-12-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20845854655501 | Argo Knotless | Conmed Corporation | 2026-09-25 |
| 20845854655518 | Argo Knotless | Conmed Corporation | 2026-09-25 |
| 09353903030201 | Griplasty System | FIELD ORTHOPAEDICS PTY LTD | 2026-06-24 |
| 10193489104523 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-10-08 |
| 09353903030003 | Griplasty System | FIELD ORTHOPAEDICS PTY LTD | 2024-09-19 |
| 10193489104516 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-07-11 |
| 00888867348691 | Arthrex® | ARTHREX, INC. | 2022-07-11 |
| 00888867280854 | Arthrex® | ARTHREX, INC. | 2020-12-15 |
| 00888867101951 | Arthrex® | ARTHREX, INC. | 2018-12-21 |
| 00888867023154 | Arthrex® | ARTHREX, INC. | 2018-08-31 |
| 00888867097025 | Arthrex® | ARTHREX, INC. | 2018-08-31 |
| 00888867280762 | Arthrex® | ARTHREX, INC. | 2018-08-31 |
| 00888867280779 | Arthrex® | ARTHREX, INC. | 2018-08-31 |
| 00888867023345 | Arthrex® | ARTHREX, INC. | 2018-08-31 |
| 00888867022966 | Arthrex® | ARTHREX, INC. | 2018-08-31 |
| 00888867022874 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867024120 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867024113 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867046672 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867028036 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867027992 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867023932 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867023925 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867023918 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867023901 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867023888 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867023871 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867023338 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867023147 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00888867022959 | Arthrex® | ARTHREX, INC. | 2017-02-15 |