MAI — Fastener, Fixation, Biodegradable, Soft Tissue Class II
FDA product code MAI covers "Fastener, Fixation, Biodegradable, Soft Tissue", a Class II medical device regulated under 21 CFR 888.3030. 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
- MAI
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253931 | arthrex | Arthrex Bioabsorbable PushLock Suture Anchors | May 28, 2026 |
| K260294 | surgical fusion technologies | SF Push-in Anchor | March 27, 2026 |
| K254055 | ossio | OSSIOfiber® Suture Anchor | February 24, 2026 |
| K251680 | biocomposites | Biosteon® Screw | February 17, 2026 |
| K252946 | conmed corporation | BioBrace® Extra-Articular Ligament Augmentation Kit | October 15, 2025 |
| K252022 | ossio | OSSIOfiber® Interference Screw | August 19, 2025 |
| K251309 | ossio | OSSIOfiber® Suture Anchor | May 27, 2025 |
| K250544 | stryker endoscopy | Knotilus+ Biocomposite Knotless Anchor | May 23, 2025 |
| K250528 | stryker endoscopy | Stryker AlphaVent Knotless SP Biocomposite Anchor | May 21, 2025 |
| K243760 | ossio | OSSIOfiber® Suture Anchor 2.5-3.5 mm | April 3, 2025 |
| K250526 | arthrex | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor | March 14, 2025 |
| K243790 | depuy mitek | GRYPHON X Anchor; HEALIX TRANSTEND Anchor | February 5, 2025 |
| K243467 | osteonic co | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | December 3, 2024 |
| K241010 | depuy mitek | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors | September 11, 2024 |
| K241912 | nanofiber solutions | BIOCHARGE | July 29, 2024 |
| K233971 | arthrex | Arthrex AlloSync PushLock Suture Anchor | June 4, 2024 |
| K240288 | surgical fusion technologies | SF Push- in Anchor | April 1, 2024 |
| K240441 | depuy mitek | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | March 15, 2024 |
| K240090 | conmed corporation | Argo Knotless GENESYS Anchor | March 5, 2024 |
| K232513 | parcus medical | X-Twist Biocomposite Suture Anchor | September 18, 2023 |