Midas Rex Legend
Model ASDS01-R · MEDTRONIC POWERED SURGICAL SOLUTIONS · DI 00763000002527
HBB — Motor, Drill, Pneumatic · Class II · 21 CFR 882.4370
HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered) · Class II · 21 CFR 882.4310
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.35 |
| 2019-02 | 0 | 3.62 |
| 2019-03 | 0 | 4.71 |
| 2019-04 | 0 | 3.36 |
| 2019-05 | 0 | 3.96 |
| 2019-06 | 0 | 3.59 |
| 2019-07 | 0 | 3.23 |
| 2019-08 | 0 | 3.41 |
| 2019-09 | 0 | 3.2 |
| 2019-10 | 0 | 3.17 |
| 2019-11 | 0 | 3.35 |
| 2019-12 | 0 | 3.77 |
| 2020-01 | 0 | 3.04 |
| 2020-02 | 0 | 5.59 |
| 2020-03 | 0 | 4.46 |
| 2020-04 | 0 | 3.17 |
| 2020-05 | 0 | 2.92 |
| 2020-06 | 0 | 4.3 |
| 2020-07 | 0 | 3.77 |
| 2020-08 | 0 | 2.84 |
| 2020-09 | 0 | 4.58 |
| 2020-10 | 0 | 3.6 |
| 2020-11 | 0 | 4.56 |
| 2020-12 | 0 | 4.08 |
| 2021-01 | 0 | 3.07 |
| 2021-02 | 0 | 2.93 |
| 2021-03 | 0 | 3.67 |
| 2021-04 | 0 | 2.92 |
| 2021-05 | 0 | 2.95 |
| 2021-06 | 0 | 3.13 |
| 2021-07 | 0 | 3.24 |
| 2021-08 | 0 | 4.24 |
| 2021-09 | 0 | 3.35 |
| 2021-10 | 0 | 2.56 |
| 2021-11 | 0 | 3.32 |
| 2021-12 | 0 | 3.96 |
| 2022-01 | 0 | 2.75 |
| 2022-02 | 0 | 3.43 |
| 2022-03 | 0 | 3.51 |
| 2022-04 | 0 | 2.46 |
| 2022-05 | 0 | 3 |
| 2022-06 | 0 | 3.69 |
| 2022-07 | 0 | 2.82 |
| 2022-08 | 0 | 3.29 |
| 2022-09 | 0 | 3.42 |
| 2022-10 | 0 | 3.08 |
| 2022-11 | 0 | 3.44 |
| 2022-12 | 0 | 4.29 |
| 2023-01 | 0 | 2.91 |
| 2023-02 | 0 | 3.36 |
| 2023-03 | 0 | 3.29 |
| 2023-04 | 0 | 3.01 |
| 2023-05 | 0 | 4.1 |
| 2023-06 | 0 | 3.68 |
| 2023-07 | 0 | 2.72 |
| 2023-08 | 0 | 3.06 |
| 2023-09 | 0 | 3.46 |
| 2023-10 | 0 | 2.53 |
| 2023-11 | 0 | 3.73 |
| 2023-12 | 0 | 2.63 |
| 2024-01 | 0 | 2.85 |
| 2024-02 | 0 | 2.76 |
| 2024-03 | 0 | 3.29 |
| 2024-04 | 0 | 2.53 |
| 2024-05 | 0 | 2.57 |
| 2024-06 | 0 | 2.92 |
| 2024-07 | 0 | 2.49 |
| 2024-08 | 0 | 2.35 |
| 2024-09 | 0 | 3.04 |
| 2024-10 | 0 | 2.42 |
| 2024-11 | 0 | 1.98 |
| 2024-12 | 0 | 3.05 |
| 2025-01 | 0 | 2.4 |
| 2025-02 | 0 | 2.52 |
| 2025-03 | 0 | 2.05 |
| 2025-04 | 0 | 1.8 |
| 2025-05 | 0 | 2.12 |
| 2025-06 | 0 | 2.29 |
| 2025-07 | 0 | 2.31 |
| 2025-08 | 0 | 2.17 |
| 2025-09 | 0 | 1.91 |
| 2025-10 | 0 | 2.7 |
| 2025-11 | 0 | 2.82 |
| 2025-12 | 0 | 2.86 |
| 2026-01 | 0 | 2.01 |
| 2026-02 | 0 | 2.4 |
| 2026-03 | 0 | 3.81 |
| 2026-04 | 0 | 4.04 |
| 2026-05 | 0 | 4.18 |
| 2026-06 | 0 | 11.22 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K191597 — cites (transitively): K131433 (d1), K151359 (d1), K162309 (d1), K162604 (d1), K163182 (d1), K170312 (d1), K101791 (d2), K101797 (d2), K050438 (d2), K133444 (d2), K153660 (d2), K012366 (d2), K992304 (d2), K020069 (d2), K072315 (d2), K090112 (d2), K870157 (d2), K012457 (d2), K081475 (d2), K121264 (d2), K001801 (d3), K023651 (d3), K092239 (d3), K991081 (d3), K002906 (d3), K042777 (d3), K060245 (d3), K081277 (d3), K150216 (d3), K992927 (d3) — cited as predicate by K203720, K210989, K213454, K223864, K243698
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — MEDTRONIC POWERED SURGICAL SOLUTIONS
- NAI 2024-12-05 Medtronic Powered Surgical Solutions · 0 citations