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"K-WIRE 4"" X.035"" .500 M1.0 THREAD"
Model 19091 · BIOPRO, INC. · DI M209190910
HTY — Pin, Fixation, Smooth · Class II · 21 CFR 888.3040
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.
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
4.49
2019-02
0
1.41
2019-03
0
1.42
2019-04
0
1.78
2019-05
0
2.05
2019-06
0
1.62
2019-07
0
2.14
2019-08
0
2
2019-09
0
3.36
2019-10
0
2.7
2019-11
0
3.24
2019-12
0
2.28
2020-01
0
2.08
2020-02
0
1.65
2020-03
0
2.33
2020-04
0
3.55
2020-05
0
1.82
2020-06
0
3.1
2020-07
0
2.36
2020-08
0
2.36
2020-09
0
1.91
2020-10
0
1.95
2020-11
0
3.5
2020-12
0
3
2021-01
0
3.21
2021-02
0
2
2021-03
0
1.8
2021-04
0
1.92
2021-05
0
2
2021-06
0
2.81
2021-07
0
1.56
2021-08
0
1.54
2021-09
0
2.53
2021-10
0
2.17
2021-11
0
1.77
2021-12
0
2.13
2022-01
0
3.44
2022-02
0
1.71
2022-03
0
3
2022-04
0
2.5
2022-05
0
2.1
2022-06
0
3
2022-07
0
2.12
2022-08
0
4.06
2022-09
0
2.79
2022-10
0
4.32
2022-11
0
2.28
2022-12
0
2.93
2023-01
0
4.82
2023-02
0
2.89
2023-03
0
3.11
2023-04
0
3.31
2023-05
0
3
2023-06
0
3.73
2023-07
0
2.75
2023-08
0
3.79
2023-09
0
3.21
2023-10
0
3.25
2023-11
0
4.3
2023-12
0
3.8
2024-01
0
3.8
2024-02
0
3.2
2024-03
0
3.53
2024-04
0
3.78
2024-05
0
2.96
2024-06
0
3.89
2024-07
0
3.06
2024-08
0
3.27
2024-09
0
3.73
2024-10
0
4.54
2024-11
0
4.15
2024-12
0
5
2025-01
0
5.6
2025-02
0
3.7
2025-03
0
3
2025-04
0
4.2
2025-05
0
3.75
2025-06
0
2.78
2025-07
0
4.1
2025-08
0
4.29
2025-09
0
3.13
2025-10
0
4.13
2025-11
0
5
2025-12
0
4.28
2026-01
0
7.08
2026-02
0
5.77
2026-03
0
4.53
2026-04
0
5.13
2026-05
0
6.25
2026-06
0
7.36
This device (reports/month)Average device in HTY (reports/device/month)