MAI
- Product code
- MAI
- Device name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3030
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 221
510(k) clearances, last 3 years (21)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262357 | 2026-08-07 | Arthrex, Inc. | Arthrex Bioabsorbable PushLock Suture Anchors | |
| K253931 | 2026-05-28 | Arthrex, Inc. | Arthrex Bioabsorbable PushLock Suture Anchors | |
| K260294 | 2026-03-27 | Surgical Fusion Technologies GmbH | SF Push-in Anchor | |
| K254055 | 2026-02-24 | OSSIO , Ltd. | OSSIOfiber® Suture Anchor | |
| K251680 | 2026-02-17 | Biocomposites, Ltd. | Biosteon® Screw | |
| K252946 | 2025-10-15 | Conmed Corporation | BioBrace® Extra-Articular Ligament Augmentation Kit | |
| K252022 | 2025-08-19 | OSSIO , Ltd. | OSSIOfiber® Interference Screw | |
| K251309 | 2025-05-27 | OSSIO , Ltd. | OSSIOfiber® Suture Anchor | |
| K250544 | 2025-05-23 | Stryker Endoscopy | Knotilus+ Biocomposite Knotless Anchor | |
| K250528 | 2025-05-21 | Stryker Endoscopy | Stryker AlphaVent Knotless SP Biocomposite Anchor | |
| K243760 | 2025-04-03 | OSSIO , Ltd. | OSSIOfiber® Suture Anchor 2.5-3.5 mm | |
| K250526 | 2025-03-14 | Arthrex, Inc. | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Sut | |
| K243790 | 2025-02-05 | Depuy Mitek | GRYPHON X Anchor; HEALIX TRANSTEND Anchor | |
| K243467 | 2024-12-03 | Osteonic Co., Ltd. | Fix2Lock (Biocomposite medial, Biocomposite lateral, | |
| K241010 | 2024-09-11 | Depuy Mitek | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self | |
| K241912 | 2024-07-29 | Nanofiber Solutions, LLC | BIOCHARGE | |
| K233971 | 2024-06-04 | Arthrex, Inc. | Arthrex AlloSync PushLock Suture Anchor | |
| K240288 | 2024-04-01 | Surgical Fusion Technologies GmbH | SF Push- in Anchor | |
| K240441 | 2024-03-15 | Depuy Mitek | MILAGRO Interference Screw; MILAGRO ADVANCE Interfer | |
| K240090 | 2024-03-05 | Conmed Corporation | Argo Knotless GENESYS Anchor | |
| K232513 | 2023-09-18 | Parcus Medical | X-Twist Biocomposite Suture Anchor |
Official FDA classification page: MAI
Classification and pathway per current FDA publications. Data from openFDA (CC0).