TruMatch
Model SD980.017 · Materialise NV · DI 05420060380174
JEY — Plate, Bone · Class II · 21 CFR 872.4760
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 (10)
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.
Injury: 10
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.41 |
| 2019-02 | 0 | 1.33 |
| 2019-03 | 0 | 2.41 |
| 2019-04 | 0 | 2.95 |
| 2019-05 | 4 | 3.31 |
| 2019-06 | 0 | 1.41 |
| 2019-07 | 0 | 1.76 |
| 2019-08 | 0 | 2 |
| 2019-09 | 0 | 2.17 |
| 2019-10 | 0 | 2.53 |
| 2019-11 | 0 | 1.72 |
| 2019-12 | 0 | 2.35 |
| 2020-01 | 0 | 2.54 |
| 2020-02 | 0 | 1.83 |
| 2020-03 | 0 | 2.06 |
| 2020-04 | 0 | 2.13 |
| 2020-05 | 0 | 2.31 |
| 2020-06 | 0 | 2 |
| 2020-07 | 0 | 2.17 |
| 2020-08 | 0 | 2.21 |
| 2020-09 | 0 | 2.06 |
| 2020-10 | 0 | 2.22 |
| 2020-11 | 0 | 1.71 |
| 2020-12 | 0 | 1.9 |
| 2021-01 | 3 | 2.13 |
| 2021-02 | 0 | 1.25 |
| 2021-03 | 0 | 2 |
| 2021-04 | 0 | 3.33 |
| 2021-05 | 0 | 4.09 |
| 2021-06 | 0 | 1.93 |
| 2021-07 | 0 | 1.33 |
| 2021-08 | 0 | 3.31 |
| 2021-09 | 0 | 1.58 |
| 2021-10 | 0 | 2.12 |
| 2021-11 | 0 | 2 |
| 2021-12 | 0 | 3.93 |
| 2022-01 | 0 | 2 |
| 2022-02 | 0 | 2.67 |
| 2022-03 | 0 | 3.5 |
| 2022-04 | 0 | 2.36 |
| 2022-05 | 0 | 1.77 |
| 2022-06 | 0 | 2.5 |
| 2022-07 | 0 | 2.16 |
| 2022-08 | 0 | 2.15 |
| 2022-09 | 0 | 1.5 |
| 2022-10 | 0 | 6.64 |
| 2022-11 | 0 | 2.27 |
| 2022-12 | 0 | 3.37 |
| 2023-01 | 0 | 2.67 |
| 2023-02 | 0 | 3.26 |
| 2023-03 | 0 | 2.67 |
| 2023-04 | 0 | 1.5 |
| 2023-05 | 0 | 2.88 |
| 2023-06 | 0 | 4.15 |
| 2023-07 | 0 | 3.81 |
| 2023-08 | 0 | 3.07 |
| 2023-09 | 0 | 2.58 |
| 2023-10 | 0 | 1.44 |
| 2023-11 | 0 | 2.68 |
| 2023-12 | 0 | 2.05 |
| 2024-01 | 0 | 2.89 |
| 2024-02 | 0 | 2.67 |
| 2024-03 | 0 | 2.23 |
| 2024-04 | 0 | 2.61 |
| 2024-05 | 0 | 2.29 |
| 2024-06 | 0 | 1.83 |
| 2024-07 | 0 | 1.55 |
| 2024-08 | 0 | 1.6 |
| 2024-09 | 0 | 2.07 |
| 2024-10 | 0 | 2.29 |
| 2024-11 | 0 | 2.75 |
| 2024-12 | 0 | 1.7 |
| 2025-01 | 0 | 1.5 |
| 2025-02 | 0 | 1.38 |
| 2025-03 | 0 | 2 |
| 2025-04 | 0 | 1.9 |
| 2025-05 | 0 | 2.27 |
| 2025-06 | 0 | 2 |
| 2025-07 | 0 | 4.1 |
| 2025-08 | 0 | 2.57 |
| 2025-09 | 0 | 1.69 |
| 2025-10 | 0 | 1.95 |
| 2025-11 | 0 | 1.53 |
| 2025-12 | 0 | 4.38 |
| 2026-01 | 0 | 1.57 |
| 2026-02 | 0 | 2.45 |
| 2026-03 | 0 | 1.11 |
| 2026-04 | 3 | 3.09 |
| 2026-05 | 0 | 2.1 |
| 2026-06 | 0 | 3.56 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K170272 — cites (transitively): K063790 (d1), K080331 (d1), K083388 (d1) — cited as predicate by K173039, K182305, K210731, K230398, K233874, K243637
K243637 — cites (transitively): K103136 (d1), K111558 (d1), K170272 (d1), K173039 (d1), K182789 (d1), K210731 (d1), K073449 (d2), K082358 (d2), K093533 (d2), K063790 (d2), K080331 (d2), K083388 (d2), K042365 (d2), K050608 (d2), K053199 (d2), K121574 (d2), K123723 (d2), K133809 (d2), K163579 (d2), K181241 (d2), K943347 (d2), K971297 (d2), K191028 (d2), K954385 (d3), K022012 (d3), K032442 (d3), K062570 (d3), K153482 (d3), K854886 (d3), K120956 (d3), K161634 (d3), K944565 (d3), K060950 (d4), K073468 (d4), K970617 (d4), K032413 (d4), K070169 (d4), K122860 (d4), K142823 (d4), K052424 (d4), K111641 (d4), K051165 (d5), K093772 (d5), K121302 (d5), K133616 (d5), K050041 (d6), K073556 (d6), K081623 (d6), K081700 (d6) — cited as predicate by K253308
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Materialise NV
Nothing in the loaded window.