FDA product code · Orthopedic · Class 2
MAI: Fastener, Fixation, Biodegradable, Soft Tissue
MAI is FDA's product code for "Fastener, Fixation, Biodegradable, Soft Tissue": a Class 2 device classified under 21 CFR 888.3030, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for MAI
Across 73 510(k) clearances under MAI decided from 2018-01-01 to 2026-10-06, the median was 78 days from FDA receipt to decision. Half took between 31 and 118 days, and 80% were decided within 157 days. These are past clearances, not a forecast for a new submission.
| Fastest | 18 |
|---|---|
| 25th percentile | 31 |
| Median | 78 |
| 75th percentile | 118 |
| 80th percentile | 157 |
| 90th percentile | 219 |
| Slowest | 389 |
| Year | Median days | n |
|---|---|---|
| 2018 | 108 | 13 |
| 2019 | 41 | 9 |
| 2020 | 78 | 9 |
| 2021 | 115 | 8 |
| 2022 | 136 | 6 |
| 2023 | 34 | 8 |
| 2024 | 53 | 7 |
| 2025 | 54 | 8 |
| 2026 (to 10-06, partial) | 69 | 5 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
MAI in the public FDA record
| 510(k) clearances, all years | 221 |
|---|---|
| Device recalls | 97 |
| Establishment listings | 1,211 |
| GUDID device identifiers | 2,284 |
Counts of records, not of devices or events. Adverse event reports for MAI are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite MAI
5 FDA recognized consensus standards cite MAI, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ASTM F1839-08 (Reapproved 2021). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-197 ASTM F983-86 (Reapproved 2018) — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-199 ASTM F565-04 (Reapproved 2018) — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-242 ASTM F1839-08 (Reapproved 2021) — Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
- 11-424 ASTM F983-24 — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-425 ASTM F565-21 — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.