MBI — Fastener, Fixation, Nondegradable, Soft Tissue Class II
FDA product code MBI covers "Fastener, Fixation, Nondegradable, Soft Tissue", a Class II medical device regulated under 21 CFR 888.3040. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261869 | anika therapeutics | Integrity Retractable Implant Inserter (6000127) | September 17, 2026 |
| K253065 | aevumed | Aevumed SUPERCYNCH Button System | September 2, 2026 |
| K262809 | arthrotak | ArthroTAK Tendon Anchor Kit | September 2, 2026 |
| K262677 | riverpoint medical | Iconix Knotless T | August 27, 2026 |
| K262047 | paragon 28 | Grappler Suture Anchor System | August 3, 2026 |
| K262369 | stryker endoscopy | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repai | July 30, 2026 |
| K261770 | skeletal dynamics | Suture Button Repair System | July 29, 2026 |
| K261632 | responsive arthroscopy | Thunderbolt System | July 20, 2026 |
| K261968 | smith and nephew | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MI | July 9, 2026 |
| K260018 | arthrex | Arthrex FiberButton | June 26, 2026 |
| K253130 | zhejiang decans medical devices co | Dione PEEK Screw System | May 27, 2026 |
| K261363 | conmed corporation | Y-Knotless Flex Anchors | May 13, 2026 |
| K253027 | ortobio | Anchor with Fiber Wire and Disposable Inserter | May 6, 2026 |
| K252635 | arthrotak | ArthroTAK Tendon Anchor Kit | May 1, 2026 |
| K260921 | tigon medical | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | April 21, 2026 |
| K260561 | arthrex | Arthrex FiberTak Suture Anchor | March 20, 2026 |
| K253886 | paragon 28 | Grappler Suture Anchor PCFD Tether System | March 17, 2026 |
| K254176 | baat medical products | SINEFIX | March 16, 2026 |
| K251750 | trax surgical | Trax EX Anchor | March 12, 2026 |
| K253693 | riverpoint medical | Strut Suture; No-Tie Button | March 11, 2026 |