Product code MBI: 510(k) clearances and predicates
Product code MBI covers Integrity Retractable Implant Inserter (6000127). FDA lists 604 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
604 clearances on file under product code MBI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 19 |
| 2023 | 52 |
| 2024 | 22 |
| 2025 | 27 |
| 2026 so far | 28 |
Recent clearances
Newest MBI clearances in the FDA index, with applicant and decision date:
- K261869, Integrity Retractable Implant Inserter (6000127), applicant Anika Therapeutics, Inc., decided 2026-09-17. FDA record
- K262809, ArthroTAK Tendon Anchor Kit, applicant ArthroTAK, LLC, decided 2026-09-02. FDA record
- K253065, Aevumed SUPERCYNCH™ Button System, applicant Aevumed, Inc., decided 2026-09-02. FDA record
- K262677, Iconix Knotless T, applicant Riverpoint Medical, decided 2026-08-27. FDA record
- K262047, Grappler Suture Anchor System, applicant Paragon 28, Inc., decided 2026-08-03. FDA record
- K262369, AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down, applicant Stryker Endoscopy, decided 2026-07-30. FDA record
- K261770, Suture Button Repair System, applicant Skeletal Dynamics, Inc., decided 2026-07-29. FDA record
- K261632, Thunderbolt System, applicant Responsive Arthroscopy, Inc., decided 2026-07-20. 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 ArthroTAK Tendon Anchor Kit, Aevumed SUPERCYNCH™ Button System. Watch new MBI 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 MBI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MBI clearances include Integrity Retractable Implant Inserter (6000127).
How many 510(k) clearances use product code MBI?
604 at the time this page was generated, from openFDA records.
How do I find a predicate device under MBI?
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 MBI 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.