Unnamed device
Model 03.402.010 · SYNTHES (U.S.A.) LP · DI 10886982079909
KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer · Class II · 21 CFR 888.3170
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 | 1.5 |
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 1.09 |
| 2019-04 | 0 | 1 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 1 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 1 |
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 1 |
| 2020-01 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-04 | 0 | 2 |
| 2020-05 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-08 | 0 | 1 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 1 |
| 2021-01 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-04 | 0 | 1 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 1.5 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 1 |
| 2021-11 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-04 | 0 | 1.4 |
| 2022-05 | 0 | 1 |
| 2022-06 | 0 | 1.5 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 1.5 |
| 2022-11 | 0 | 1.4 |
| 2022-12 | 0 | 1.67 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 1 |
| 2023-04 | 0 | 1 |
| 2023-05 | 0 | 1 |
| 2023-07 | 0 | 2.33 |
| 2023-08 | 0 | 1.33 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 1 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1 |
| 2024-01 | 0 | 1 |
| 2024-02 | 0 | 2 |
| 2024-03 | 0 | 1 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 1 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1.67 |
| 2024-08 | 0 | 1.25 |
| 2024-09 | 0 | 2.23 |
| 2024-10 | 0 | 2 |
| 2024-11 | 0 | 1 |
| 2025-03 | 0 | 1.62 |
| 2025-04 | 0 | 1 |
| 2025-07 | 0 | 1 |
| 2025-08 | 0 | 1.5 |
| 2025-09 | 0 | 1 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 1 |
| 2026-03 | 0 | 1.5 |
| 2026-04 | 0 | 1 |
| 2026-05 | 0 | 2 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K112030 — cites (transitively): K032686 (d1), K033984 (d1), K051385 (d1), K053088 (d1), K072578 (d1), K080615 (d1), K083439 (d1), K083714 (d1), K100889 (d1), K102067 (d1), K082801 (d2), P980048 (d2), P950002 (d2), P950019 (d2), P960025 (d2)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SYNTHES (U.S.A.) LP
Nothing in the loaded window.