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Signature
Model 42-422557 · Materialise NV · DI E314424225570
JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560
MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer · Class II · 21 CFR 888.3565
OIY — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive · Class II · 21 CFR 888.3560
OOG — Knee Arthroplasty Implantation System · Class II · 21 CFR 888.3560
UDILibrary device dossier · generated 2026-09-12 · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2.26
2019-02
0
2.02
2019-03
0
1.67
2019-04
0
2
2019-05
0
1.87
2019-06
0
2.06
2019-07
0
2.08
2019-08
0
2.37
2019-09
0
2.02
2019-10
0
2.48
2019-11
0
3.26
2019-12
0
2.46
2020-01
0
2.41
2020-02
0
2.55
2020-03
0
2.15
2020-04
0
2
2020-05
0
1.69
2020-06
0
1.95
2020-07
0
2.41
2020-08
0
2.44
2020-09
0
2.09
2020-10
0
2.58
2020-11
0
2.59
2020-12
0
2.58
2021-01
0
2.16
2021-02
0
2.18
2021-03
0
2.32
2021-04
0
2.19
2021-05
0
2.18
2021-06
0
2.09
2021-07
0
2.11
2021-08
0
1.81
2021-09
0
2.15
2021-10
0
1.85
2021-11
0
2.05
2021-12
0
2.17
2022-01
0
1.84
2022-02
0
2.13
2022-03
0
1.87
2022-04
0
1.94
2022-05
0
2.09
2022-06
0
1.85
2022-07
0
1.89
2022-08
0
1.91
2022-09
0
2.08
2022-10
0
1.96
2022-11
0
2.06
2022-12
0
1.71
2023-01
0
1.86
2023-02
0
1.99
2023-03
0
1.96
2023-04
0
2.01
2023-05
0
2.1
2023-06
0
2
2023-07
0
1.78
2023-08
0
1.55
2023-09
0
1.57
2023-10
0
1.47
2023-11
0
1.53
2023-12
0
1.55
2024-01
0
1.43
2024-02
0
1.59
2024-03
0
1.62
2024-04
0
1.51
2024-05
0
1.68
2024-06
0
1.75
2024-07
0
1.62
2024-08
0
2.04
2024-09
0
1.77
2024-10
0
1.79
2024-11
0
1.72
2024-12
0
1.8
2025-01
0
1.99
2025-02
0
1.64
2025-03
0
1.6
2025-04
0
1.51
2025-05
0
1.56
2025-06
0
1.61
2025-07
0
1.49
2025-08
0
1.5
2025-09
0
1.48
2025-10
0
1.34
2025-11
0
1.52
2025-12
0
1.56
2026-01
0
1.46
2026-02
0
1.42
2026-03
0
1.7
2026-04
0
1.56
2026-05
0
1.52
2026-06
0
1.52
This device (reports/month)Average device in JWH, MBH, OIY, OOG (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K102795 — cites (transitively): K073449 (d1), K093533 (d1), K082358 (d2) — cited as predicate by K111863, K113829, K140257, K150928, K190904
Lineage extracted from public 510(k) summary text (heuristic).