Product code MAI: 510(k) clearances and predicates
Product code MAI covers Arthrex Bioabsorbable PushLock Suture Anchors. FDA lists 221 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
221 clearances on file under product code MAI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 6 |
| 2023 | 8 |
| 2024 | 7 |
| 2025 | 8 |
| 2026 so far | 5 |
Recent clearances
Newest MAI clearances in the FDA index, with applicant and decision date:
- K262357, Arthrex Bioabsorbable PushLock Suture Anchors, applicant Arthrex, Inc., decided 2026-08-07. FDA record
- K253931, Arthrex Bioabsorbable PushLock Suture Anchors, applicant Arthrex, Inc., decided 2026-05-28. FDA record
- K260294, SF Push-in Anchor, applicant Surgical Fusion Technologies GmbH, decided 2026-03-27. FDA record
- K254055, OSSIOfiber® Suture Anchor, applicant OSSIO , Ltd., decided 2026-02-24. FDA record
- K251680, Biosteon® Screw, applicant Biocomposites, Ltd., decided 2026-02-17. FDA record
- K252946, BioBrace® Extra-Articular Ligament Augmentation Kit, applicant Conmed Corporation, decided 2025-10-15. FDA record
- K252022, OSSIOfiber® Interference Screw, applicant OSSIO , Ltd., decided 2025-08-19. FDA record
- K251309, OSSIOfiber® Suture Anchor, applicant OSSIO , Ltd., decided 2025-05-27. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include OSSIOfiber® Suture Anchor, SF Push-in Anchor. Watch new MAI clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code MAI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MAI clearances include Arthrex Bioabsorbable PushLock Suture Anchors.
How many 510(k) clearances use product code MAI?
221 at the time this page was generated, from openFDA records.
How do I find a predicate device under MAI?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new MAI clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.