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AcuTie
Model STW1101 · ACUTE INNOVATIONS LLC · DI 10814493010753
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
JDQ — Cerclage, Fixation · Class II · 21 CFR 888.3010
KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-15 · 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
2.03
2019-02
0
1.57
2019-03
0
1.61
2019-04
0
2.22
2019-05
0
1.72
2019-06
0
1.77
2019-07
0
2.11
2019-08
0
1.99
2019-09
0
1.77
2019-10
0
1.64
2019-11
0
1.87
2019-12
0
2.35
2020-01
0
2.44
2020-02
0
2.17
2020-03
0
1.81
2020-04
0
1.8
2020-05
0
1.65
2020-06
0
2.07
2020-07
0
2.51
2020-08
0
2.4
2020-09
0
2.43
2020-10
0
2.26
2020-11
0
2.61
2020-12
0
2.43
2021-01
0
1.81
2021-02
0
2.35
2021-03
0
2.59
2021-04
0
2.69
2021-05
0
2.48
2021-06
0
2.15
2021-07
0
2.17
2021-08
0
2.02
2021-09
0
2.4
2021-10
0
1.98
2021-11
0
2.37
2021-12
0
2.25
2022-01
0
2.78
2022-02
0
2.32
2022-03
0
2.04
2022-04
0
1.99
2022-05
0
2.56
2022-06
0
2.2
2022-07
0
2.16
2022-08
0
2.42
2022-09
0
2.83
2022-10
0
3.05
2022-11
0
3.08
2022-12
0
5.03
2023-01
0
2.75
2023-02
0
2.79
2023-03
0
3.02
2023-04
0
2.71
2023-05
0
3.29
2023-06
0
2.86
2023-07
0
2.28
2023-08
0
2.04
2023-09
0
2.11
2023-10
0
2.06
2023-11
0
1.82
2023-12
0
2.32
2024-01
0
2.62
2024-02
0
1.81
2024-03
0
2.2
2024-04
0
2.13
2024-05
0
2.2
2024-06
0
2.2
2024-07
0
2.43
2024-08
0
2.08
2024-09
0
2.04
2024-10
0
2.18
2024-11
0
2.01
2024-12
0
2.84
2025-01
0
2.13
2025-02
0
2.11
2025-03
0
1.99
2025-04
0
2.55
2025-05
0
2.57
2025-06
0
1.95
2025-07
0
2.09
2025-08
0
2.27
2025-09
0
2.01
2025-10
0
2.44
2025-11
0
2.02
2025-12
0
2.63
2026-01
0
2.02
2026-02
0
2.25
2026-03
0
2.46
2026-04
0
2.15
2026-05
0
2.64
2026-06
0
2.25
This device (reports/month)Average device in HWC, JDQ, KTT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — ACUTE INNOVATIONS LLC
VAI 2016-01-28 ACUTE Innovations LLC · 2 citations
VAI 2013-04-19 ACUTE Innovations LLC · 2 citations
VAI 2011-10-21 ACUTE Innovations LLC · 4 citations
NAI 2010-08-19 ACUTE Innovations LLC · 0 citations