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Unnamed device
Model 259.46 · SYNTHES (U.S.A.) LP · DI 10886982172631
HSB — Rod, Fixation, Intramedullary And Accessories · Class II · 21 CFR 888.3020
JDS — Nail, Fixation, Bone · Class II · 21 CFR 888.3030
JDW — Pin, Fixation, Threaded · Class II · 21 CFR 888.3040
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
1.46
2019-02
0
1.52
2019-03
0
1.51
2019-04
0
1.36
2019-05
0
1.48
2019-06
0
1.58
2019-07
0
1.61
2019-08
0
2.69
2019-09
0
1.35
2019-10
0
1.54
2019-11
0
1.83
2019-12
0
1.66
2020-01
0
1.8
2020-02
0
1.52
2020-03
0
1.5
2020-04
0
1.95
2020-05
0
1.78
2020-06
0
2.17
2020-07
0
2.18
2020-08
0
2.81
2020-09
0
2.17
2020-10
0
2.38
2020-11
0
3.11
2020-12
0
3.16
2021-01
0
2.79
2021-02
0
2.93
2021-03
0
3.27
2021-04
0
3.28
2021-05
0
4.39
2021-06
0
2.97
2021-07
0
2.35
2021-08
0
2.3
2021-09
0
2.15
2021-10
0
1.8
2021-11
0
3.16
2021-12
0
2.31
2022-01
0
2.77
2022-02
0
2.14
2022-03
0
2.19
2022-04
0
2.21
2022-05
0
1.99
2022-06
0
2.25
2022-07
0
1.87
2022-08
0
1.95
2022-09
0
2.66
2022-10
0
2.46
2022-11
0
2.66
2022-12
0
2.32
2023-01
0
2.37
2023-02
0
2.44
2023-03
0
2.87
2023-04
0
2.45
2023-05
0
2.89
2023-06
0
2.78
2023-07
0
2.01
2023-08
0
1.76
2023-09
0
1.49
2023-10
0
1.5
2023-11
0
1.51
2023-12
0
1.57
2024-01
0
1.8
2024-02
0
1.52
2024-03
0
1.74
2024-04
0
1.47
2024-05
0
1.68
2024-06
0
1.75
2024-07
0
1.43
2024-08
0
1.9
2024-09
0
2.19
2024-10
0
1.74
2024-11
0
1.8
2024-12
0
1.88
2025-01
0
1.94
2025-02
0
1.82
2025-03
0
1.7
2025-04
0
2.22
2025-05
0
1.76
2025-06
0
1.5
2025-07
0
1.75
2025-08
0
1.71
2025-09
0
1.61
2025-10
0
1.74
2025-11
0
1.95
2025-12
0
2
2026-01
0
1.96
2026-02
0
1.75
2026-03
0
1.8
2026-04
0
1.66
2026-05
0
1.78
2026-06
0
1.71
This device (reports/month)Average device in HSB, JDS, JDW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K914371 — cited as predicate by K182783
K914453 — cited as predicate by K111056, K133166, K182783, K233150
K970097 — cited as predicate by K132945, K182783, K192003, K233134
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SYNTHES (U.S.A.) LP