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1.5 mm Inion CPS®
Model 1 · Inion Oy · DI 06438408011504
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
JEY — Plate, Bone · Class II · 21 CFR 872.4760
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
2.05
2019-02
0
1.57
2019-03
0
1.84
2019-04
0
2.35
2019-05
0
1.92
2019-06
0
1.76
2019-07
0
1.99
2019-08
0
2.02
2019-09
0
1.78
2019-10
0
1.79
2019-11
0
1.92
2019-12
0
2.5
2020-01
0
2.55
2020-02
0
2.08
2020-03
0
1.93
2020-04
0
1.91
2020-05
0
1.83
2020-06
0
2.05
2020-07
0
2.59
2020-08
0
2.43
2020-09
0
2.4
2020-10
0
2.22
2020-11
0
2.67
2020-12
0
2.44
2021-01
0
1.86
2021-02
0
2.16
2021-03
0
2.55
2021-04
0
2.77
2021-05
0
2.54
2021-06
0
2.18
2021-07
0
2.22
2021-08
0
2.19
2021-09
0
2.26
2021-10
0
2.08
2021-11
0
2.24
2021-12
0
2.58
2022-01
0
2.86
2022-02
0
2.26
2022-03
0
2.18
2022-04
0
1.98
2022-05
0
2.31
2022-06
0
2.26
2022-07
0
2.18
2022-08
0
2.43
2022-09
0
2.8
2022-10
0
3.26
2022-11
0
2.94
2022-12
0
5.08
2023-01
0
2.71
2023-02
0
2.9
2023-03
0
3.03
2023-04
0
2.69
2023-05
0
3.27
2023-06
0
3.13
2023-07
0
2.44
2023-08
0
2.25
2023-09
0
2.07
2023-10
0
2.09
2023-11
0
1.98
2023-12
0
2.39
2024-01
0
2.77
2024-02
0
1.88
2024-03
0
2.33
2024-04
0
2.16
2024-05
0
2.3
2024-06
0
2.22
2024-07
0
2.38
2024-08
0
2.1
2024-09
0
2.14
2024-10
0
2.21
2024-11
0
2.07
2024-12
0
2.67
2025-01
0
2.17
2025-02
0
2.13
2025-03
0
2.06
2025-04
0
2.49
2025-05
0
2.47
2025-06
0
2.01
2025-07
0
2.26
2025-08
0
2.4
2025-09
0
2.03
2025-10
0
2.38
2025-11
0
1.97
2025-12
0
2.97
2026-01
0
1.94
2026-02
0
2.38
2026-03
0
2.45
2026-04
0
2.3
2026-05
0
2.51
2026-06
0
2.44
This device (reports/month)Average device in HWC, JEY (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K010352 — cited as predicate by K122890, K251441, K251472
K020266 — cited as predicate by K251441
Lineage extracted from public 510(k) summary text (heuristic).