FDA product code MAI: Fastener, Fixation, Biodegradable, Soft Tissue
MAI is the FDA product code for fastener, fixation, biodegradable, soft tissue. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 219 510(k) submissions under MAI, 32 in the last five years, from 65 different applicants. The average 510(k) review took 108 days (median 85); 88 days on average over the last three years. FDA has posted 96 recalls for MAI devices, 13 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MAI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 125 |
| 2018 | 13 | 120 |
| 2019 | 9 | 59 |
| 2020 | 9 | 101 |
| 2021 | 8 | 159 |
| 2022 | 6 | 121 |
| 2023 | 8 | 72 |
| 2024 | 7 | 74 |
| 2025 | 8 | 59 |
| 2026 | 3 | 130 |
Top MAI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arthrex, Inc. | 44 | 2025-03-14 |
| Depuy Mitek, A Johnson & Johnson Company | 18 | 2015-05-21 |
| Linvatec Corp. | 11 | 2009-06-22 |
| Smith & Nephew, Inc. | 10 | 2020-03-18 |
| Medos International SARL | 8 | 2019-08-22 |
60 more applicants have MAI clearances. See the full list in Caduvo.
Most recent MAI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260294 | Surgical Fusion Technologies GmbH | SF Push-in Anchor | 2026-03-27 | 57 |
| K254055 | OSSIO , Ltd. | OSSIOfiber® Suture Anchor | 2026-02-24 | 69 |
| K251680 | Biocomposites, Ltd. | Biosteon® Screw | 2026-02-17 | 263 |
| K252946 | Conmed Corporation | BioBrace® Extra-Articular Ligament Augmentation Kit | 2025-10-15 | 30 |
| K252022 | OSSIO , Ltd. | OSSIOfiber® Interference Screw | 2025-08-19 | 50 |
Recalls for MAI devices
96 product recalls in 15 recall events; 13 initiated in the last five years and 54 still open. Most recent: 2025-12-17.
| Year | Recalls |
|---|---|
| 2017 | 7 |
| 2019 | 2 |
| 2020 | 40 |
| 2021 | 2 |
| 2023 | 5 |
| 2025 | 8 |
Frequently asked questions
What is FDA product code MAI?
MAI is the FDA product code for fastener, fixation, biodegradable, soft tissue. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is MAI?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code MAI?
Across 219 cleared submissions the average was 108 days from receipt to decision (median 85).
Which companies have the most MAI clearances?
Arthrex, Inc. (44); Depuy Mitek, A Johnson & Johnson Company (18); Linvatec Corp. (11); Smith & Nephew, Inc. (10); Medos International SARL (8).
Have MAI devices been recalled?
Yes: 96 product recalls across 15 recall events; the most recent began 2025-12-17.
Next steps
- Run an FDA pathway report with predicate devices for product code MAI
- Run a recall and safety report across every MAI manufacturer
- Watch product code MAI 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.