MBI — Fastener, Fixation, Nondegradable, Soft Tissue Class II
FDA Device Classification
Classification Details
- Product Code
- MBI
- Device Class
- Class II
- Regulation Number
- 888.3040
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251750 | trax surgical | Trax EX Anchor | March 12, 2026 |
| K253693 | riverpoint medical | Strut Suture; No-Tie Button | March 11, 2026 |
| K260405 | arthrex | FiberTape Button | March 9, 2026 |
| K253538 | theramicro | TeKBrace Knotless Anchor | March 6, 2026 |
| K254306 | aevumed | Aevumed FENIX Suture Anchor | March 4, 2026 |
| K254229 | arthrex | Arthrex Nano FiberTak Suture Anchor | March 2, 2026 |
| K253695 | riverpoint medical | LigaMend | February 27, 2026 |
| K253763 | conmed corporation | Y-Knotless Flex Anchors | January 29, 2026 |
| K260004 | aevumed | Aevumed PROTEKT Suture Anchor | January 28, 2026 |
| K253618 | abanza tecnomed s.l | QuadLock Fixation System | January 6, 2026 |
| K253895 | arthrex | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | December 30, 2025 |
| K252596 | tigon medical | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | December 4, 2025 |
| K252664 | gm dos reis industria e comercio ltda | GMReis Suture Anchors | November 4, 2025 |
| K252314 | arthrex | Arthrex SutureTak Suture Anchor | October 29, 2025 |
| K253040 | aevumed | Aevumed FASE Suture Anchor | October 21, 2025 |
| K253010 | responsive arthroscopy | Mini Superhawk Suture Anchor System | October 14, 2025 |
| K250095 | suturetech | All-Suture Dual Anchor System | September 5, 2025 |
| K242895 | aevumed | Aevumed PHANTOM Suture Anchors | August 6, 2025 |
| K252144 | riverpoint medical | Iconix Speed Anchor; Iconix Speed HA+ Anchor | July 30, 2025 |
| K251310 | ots medical | OTS 25-L (100-5) | July 22, 2025 |