FDA product code MBI: Fastener, Fixation, Nondegradable, Soft Tissue
MBI is the FDA product code for fastener, fixation, nondegradable, soft tissue. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. FDA has cleared 604 510(k) submissions under MBI, 148 in the last five years, from 164 different applicants. The average 510(k) review took 101 days (median 80); 86 days on average over the last three years. FDA has posted 113 recalls for MBI devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MBI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 17 | 75 |
| 2018 | 16 | 115 |
| 2019 | 31 | 105 |
| 2020 | 35 | 124 |
| 2021 | 18 | 114 |
| 2022 | 19 | 153 |
| 2023 | 52 | 94 |
| 2024 | 22 | 75 |
| 2025 | 27 | 83 |
| 2026 | 28 | 99 |
Compare with all 510(k) review times · Search every MBI clearance
Top MBI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrex, Inc. | 52 | 2026-06-26 |
| Innovasive Devices, Inc. | 22 | 1999-10-14 |
| Parcus Medical, LLC | 21 | 2022-07-26 |
| Smith & Nephew, Inc. | 20 | 2026-07-09 |
| Arthrocare Corp. | 18 | 2016-01-28 |
159 more applicants have MBI clearances. See the full list in Caduvo.
Most recent MBI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261869 | Anika Therapeutics, Inc. | Integrity Retractable Implant Inserter (6000127) | 2026-09-17 | 105 |
| K253065 | Aevumed, Inc. | Aevumed SUPERCYNCH Button System | 2026-09-02 | 345 |
| K262809 | ArthroTAK, LLC | ArthroTAK Tendon Anchor Kit | 2026-09-02 | 26 |
| K262677 | Riverpoint Medical | Iconix Knotless T | 2026-08-27 | 28 |
| K262047 | Paragon 28, Inc. | Grappler Suture Anchor System | 2026-08-03 | 46 |
Recalls for MBI devices
113 product recalls in 48 recall events; 9 initiated in the last five years and 13 still open. Most recent: 2025-09-23.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 4 |
| 2019 | 3 |
| 2020 | 6 |
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code MBI?
MBI is the FDA product code for fastener, fixation, nondegradable, soft tissue. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is MBI?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code MBI?
Across 604 cleared submissions the average was 101 days from receipt to decision (median 80).
Which companies have the most MBI clearances?
Arthrex, Inc. (52); Innovasive Devices, Inc. (22); Parcus Medical, LLC (21); Smith & Nephew, Inc. (20); Arthrocare Corp. (18).
Have MBI devices been recalled?
Yes: 113 product recalls across 48 recall events; the most recent began 2025-09-23.
Next steps
- Run an FDA pathway report with predicate devices for product code MBI
- Run a recall and safety report across every MBI manufacturer
- Watch product code MBI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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