Paradigm
Model 1200004 · Proprio, Inc. · DI 00850042604069
OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560
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 | 2.67 |
| 2019-02 | 0 | 3.61 |
| 2019-03 | 0 | 3.19 |
| 2019-04 | 0 | 2.75 |
| 2019-05 | 0 | 3.1 |
| 2019-06 | 0 | 2.72 |
| 2019-07 | 0 | 3.23 |
| 2019-08 | 0 | 2.93 |
| 2019-09 | 0 | 2.89 |
| 2019-10 | 0 | 3.84 |
| 2019-11 | 0 | 5.54 |
| 2019-12 | 0 | 3.54 |
| 2020-01 | 0 | 3.39 |
| 2020-02 | 0 | 4.56 |
| 2020-03 | 0 | 4.41 |
| 2020-04 | 0 | 7.69 |
| 2020-05 | 0 | 2.37 |
| 2020-06 | 0 | 3.54 |
| 2020-07 | 0 | 3.94 |
| 2020-08 | 0 | 2.61 |
| 2020-09 | 0 | 3.93 |
| 2020-10 | 0 | 5.63 |
| 2020-11 | 0 | 5.77 |
| 2020-12 | 0 | 4.33 |
| 2021-01 | 0 | 4.68 |
| 2021-02 | 0 | 4.08 |
| 2021-03 | 0 | 3.82 |
| 2021-04 | 0 | 3.82 |
| 2021-05 | 0 | 4.15 |
| 2021-06 | 0 | 3.79 |
| 2021-07 | 0 | 3.25 |
| 2021-08 | 0 | 2.96 |
| 2021-09 | 0 | 2.92 |
| 2021-10 | 0 | 2.27 |
| 2021-11 | 0 | 4.24 |
| 2021-12 | 0 | 2.72 |
| 2022-01 | 0 | 2.54 |
| 2022-02 | 0 | 3.16 |
| 2022-03 | 0 | 3.32 |
| 2022-04 | 0 | 2.45 |
| 2022-05 | 0 | 3.91 |
| 2022-06 | 0 | 4.21 |
| 2022-07 | 0 | 3.33 |
| 2022-08 | 0 | 2.9 |
| 2022-09 | 0 | 2.32 |
| 2022-10 | 0 | 3.76 |
| 2022-11 | 0 | 3.44 |
| 2022-12 | 0 | 4.22 |
| 2023-01 | 0 | 3.18 |
| 2023-02 | 0 | 3.44 |
| 2023-03 | 0 | 3.77 |
| 2023-04 | 0 | 3.26 |
| 2023-05 | 0 | 3.02 |
| 2023-06 | 0 | 2.6 |
| 2023-07 | 0 | 2.69 |
| 2023-08 | 0 | 2.51 |
| 2023-09 | 0 | 4.04 |
| 2023-10 | 0 | 3.21 |
| 2023-11 | 0 | 9.13 |
| 2023-12 | 0 | 4 |
| 2024-01 | 0 | 3.71 |
| 2024-02 | 0 | 4.15 |
| 2024-03 | 0 | 4.4 |
| 2024-04 | 0 | 3.95 |
| 2024-05 | 0 | 4.89 |
| 2024-06 | 0 | 4.54 |
| 2024-07 | 0 | 3.92 |
| 2024-08 | 0 | 4.59 |
| 2024-09 | 0 | 4.53 |
| 2024-10 | 0 | 6.31 |
| 2024-11 | 0 | 4.74 |
| 2024-12 | 0 | 4.01 |
| 2025-01 | 0 | 8.37 |
| 2025-02 | 0 | 4.23 |
| 2025-03 | 0 | 3.59 |
| 2025-04 | 0 | 4.2 |
| 2025-05 | 0 | 4.57 |
| 2025-06 | 0 | 4.14 |
| 2025-07 | 0 | 4.32 |
| 2025-08 | 0 | 5.03 |
| 2025-09 | 0 | 3.85 |
| 2025-10 | 0 | 3.97 |
| 2025-11 | 0 | 4.12 |
| 2025-12 | 0 | 4.59 |
| 2026-01 | 0 | 4.53 |
| 2026-02 | 0 | 4.25 |
| 2026-03 | 0 | 4.08 |
| 2026-04 | 0 | 3.9 |
| 2026-05 | 0 | 4.99 |
| 2026-06 | 0 | 3.99 |
Regulatory clearances
- K222291 SESE 2023-04-21 (k number procode)
Predicate lineage
K222291 — cites (transitively): K033621 (d1), K162375 (d1), K133444 (d2), K050438 (d3) — cited as predicate by K243258
K243258 — cites (transitively): K033621 (d1), K222291 (d1), K162375 (d2), K133444 (d3), K050438 (d4) — cited as predicate by K250879
K250879 — cites (transitively): K033621 (d1), K243258 (d1), K222291 (d2), K162375 (d3), K133444 (d4), K050438 (d5) — cited as predicate by K252950
K252950 — cites (transitively): K033621 (d1), K250879 (d1), K243258 (d2), K222291 (d3), K162375 (d4), K133444 (d5), K050438 (d6)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Proprio, Inc.
Nothing in the loaded window.