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Key Surgical K-Wires and Steinmann Pins
Model KI-71-030 · KEY SURGICAL, INC. · DI 00849771012139
HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030
HTY — Pin, Fixation, Smooth · Class II · 21 CFR 888.3040
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
UDILibrary device dossier · generated 2026-09-13 · 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
2.35
2019-02
0
1.57
2019-03
0
1.73
2019-04
0
2.27
2019-05
0
1.75
2019-06
0
1.73
2019-07
0
1.92
2019-08
0
1.86
2019-09
0
1.84
2019-10
0
1.68
2019-11
0
2.03
2019-12
0
2.26
2020-01
0
2.38
2020-02
0
1.44
2020-03
0
1.83
2020-04
0
2.02
2020-05
0
1.77
2020-06
0
2.06
2020-07
0
2.34
2020-08
0
2.42
2020-09
0
2.55
2020-10
0
2.08
2020-11
0
2.71
2020-12
0
2.45
2021-01
0
1.89
2021-02
0
2.13
2021-03
0
2.36
2021-04
0
2.71
2021-05
0
2.48
2021-06
0
2.19
2021-07
0
2.25
2021-08
0
1.96
2021-09
0
2.24
2021-10
0
2.06
2021-11
0
2.16
2021-12
0
2.28
2022-01
0
2.98
2022-02
0
2.11
2022-03
0
1.98
2022-04
0
2
2022-05
0
2.2
2022-06
0
2.33
2022-07
0
2.2
2022-08
0
2.44
2022-09
0
2.71
2022-10
0
3.1
2022-11
0
2.91
2022-12
0
4.42
2023-01
0
2.85
2023-02
0
2.76
2023-03
0
3.05
2023-04
0
2.93
2023-05
0
3.57
2023-06
0
2.99
2023-07
0
2.29
2023-08
0
2.28
2023-09
0
2.16
2023-10
0
2.31
2023-11
0
2.12
2023-12
0
2.56
2024-01
0
2.6
2024-02
0
1.85
2024-03
0
2.27
2024-04
0
2.22
2024-05
0
2.23
2024-06
0
2.42
2024-07
0
2.44
2024-08
0
2.27
2024-09
0
2.03
2024-10
0
2.4
2024-11
0
2.07
2024-12
0
2.93
2025-01
0
2.29
2025-02
0
2.16
2025-03
0
2.38
2025-04
0
2.43
2025-05
0
2.49
2025-06
0
1.97
2025-07
0
2.27
2025-08
0
2.38
2025-09
0
2.05
2025-10
0
2.44
2025-11
0
2.18
2025-12
0
2.77
2026-01
0
2.32
2026-02
0
2.43
2026-03
0
2.9
2026-04
0
2.4
2026-05
0
2.68
2026-06
0
2.42
This device (reports/month)Average device in HRS, HTY, HWC (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K102845 — cites (transitively): K082527 (d1), K083654 (d1), K083912 (d1), K091614 (d1) — cited as predicate by K172943
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — KEY SURGICAL, INC.