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Materialise Personalized Solutions
Model O-01-0-105000-0011-010 · Materialise NV · DI 05420060343285
PBF — Orthopaedic Surgical Planning And Instrument Guides · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-11 · 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 (3)
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: 3
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-11
0
1
2019-12
0
3
2020-01
0
4
2020-07
0
1
2020-09
0
2
2021-04
0
1
2021-05
0
1
2021-06
0
1
2022-03
0
2
2022-06
0
1
2022-07
3
2.67
2022-11
0
1
2022-12
0
1
2023-05
0
1
2023-10
0
1
2024-05
0
1
2024-08
0
1
2024-10
0
1
2025-08
0
2
2025-11
0
1
2025-12
0
1
2026-03
0
1
2026-04
0
1
This device (reports/month)Average device in PBF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K112389 — cited as predicate by K132290, K143374
K163156 — cites (transitively): K132290 (d1), K112389 (d2) — cited as predicate by K220717, K221615, K240415
Lineage extracted from public 510(k) summary text (heuristic).