Print-ready dossier — use your browser's print dialog to save as PDF.
AOS THREADED CENTER PIN 6.0mm x 280mm
Model 1161 · ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · DI 00848665005523
JDW — Pin, Fixation, Threaded · Class II · 21 CFR 888.3040
JEC — Component, Traction, Invasive · Class II · 21 CFR 888.3040
KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component · Class II · 21 CFR 888.3030
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
1.56
2019-02
0
1.61
2019-03
0
1.3
2019-04
0
2
2019-05
0
1.54
2019-06
0
1.59
2019-07
0
2
2019-08
0
4.5
2019-09
0
1.38
2019-10
0
1.22
2019-11
0
1.5
2019-12
0
1.64
2020-01
0
2.31
2020-02
0
2.34
2020-03
0
1.5
2020-04
0
1.5
2020-05
0
1.23
2020-06
0
2
2020-07
0
1.43
2020-08
0
2
2020-09
0
2.38
2020-10
0
2.21
2020-11
0
1.91
2020-12
0
2.27
2021-01
0
1.59
2021-02
0
2.84
2021-03
0
3.15
2021-04
0
2.43
2021-05
0
4.26
2021-06
0
2.07
2021-07
0
1.74
2021-08
0
1.66
2021-09
0
1.67
2021-10
0
1.58
2021-11
0
2.79
2021-12
0
1.61
2022-01
0
2
2022-02
0
2.71
2022-03
0
2.05
2022-04
0
2.39
2022-05
0
3.83
2022-06
0
2.35
2022-07
0
2.09
2022-08
0
2
2022-09
0
2.43
2022-10
0
2.81
2022-11
0
3.37
2022-12
0
2.36
2023-01
0
2.63
2023-02
0
2.1
2023-03
0
1.96
2023-04
0
2.16
2023-05
0
2.87
2023-06
0
2.07
2023-07
0
2.03
2023-08
0
1.46
2023-09
0
2.11
2023-10
0
1.18
2023-11
0
1.5
2023-12
0
1.33
2024-01
0
1.18
2024-02
0
2
2024-03
0
1.35
2024-04
0
1.73
2024-05
0
1.42
2024-06
0
1.46
2024-07
0
1.08
2024-08
0
1.63
2024-09
0
1.24
2024-10
0
1.82
2024-11
0
1.65
2024-12
0
3.8
2025-01
0
1.5
2025-02
0
2
2025-03
0
1.25
2025-04
0
2
2025-05
0
1.44
2025-06
0
1.28
2025-07
0
1.73
2025-08
0
1.22
2025-09
0
1.47
2025-10
0
2.45
2025-11
0
1.78
2025-12
0
1.64
2026-01
0
1.5
2026-02
0
1.3
2026-03
0
1.29
2026-04
0
1.25
2026-05
0
3
2026-06
0
1.33
This device (reports/month)Average device in JDW, JEC, KTT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.