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Humelock II Cemented Shoulder System
Model 105-0004 · FX SOLUTIONS · DI 03701037300190
KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650
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 (3)
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.
Injury: 3
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
1.88
2019-02
0
1.44
2019-03
0
1.27
2019-04
0
2.33
2019-05
0
2.31
2019-06
0
2
2019-07
0
1.71
2019-08
0
2.15
2019-09
0
1.69
2019-10
0
2.11
2019-11
0
1.36
2019-12
0
2.15
2020-01
0
1.79
2020-02
0
2.04
2020-03
0
1.83
2020-04
0
1.38
2020-05
0
2.18
2020-06
0
2.32
2020-07
0
1.88
2020-08
0
2.32
2020-09
0
2.5
2020-10
0
2.65
2020-11
0
2.54
2020-12
0
1.92
2021-01
0
2
2021-02
0
1.52
2021-03
0
1.81
2021-04
0
1.97
2021-05
0
1.41
2021-06
0
1.41
2021-07
0
2.47
2021-08
0
2.5
2021-09
0
1.88
2021-10
0
2.21
2021-11
0
1.82
2021-12
0
2.3
2022-01
0
2.25
2022-02
0
2.64
2022-03
0
2.26
2022-04
3
2.19
2022-05
0
1.68
2022-06
0
2.69
2022-07
0
2.44
2022-08
0
2.08
2022-09
0
1.98
2022-10
0
1.64
2022-11
0
1.92
2022-12
0
2
2023-01
0
1.71
2023-02
0
1.67
2023-03
0
1.63
2023-04
0
1.66
2023-05
0
1.7
2023-06
0
1.75
2023-07
0
1.97
2023-08
0
1.7
2023-09
0
1.48
2023-10
0
1.44
2023-11
0
1.66
2023-12
0
1.37
2024-01
0
1.6
2024-02
0
2.17
2024-03
0
1.63
2024-04
0
1.89
2024-05
0
1.7
2024-06
0
1.88
2024-07
0
1.6
2024-08
0
1.62
2024-09
0
1.81
2024-10
0
1.74
2024-11
0
1.8
2024-12
0
1.89
2025-01
0
1.79
2025-02
0
1.81
2025-03
0
1.75
2025-04
0
2.24
2025-05
0
2.2
2025-06
0
1.84
2025-07
0
1.52
2025-08
0
1.95
2025-09
0
1.36
2025-10
0
1.54
2025-11
0
1.73
2025-12
0
2.04
2026-01
0
1.76
2026-02
0
1.47
2026-03
0
1.7
2026-04
0
1.72
2026-05
0
1.59
2026-06
0
1.56
This device (reports/month)Average device in KWT (reports/device/month)
Regulatory clearances
K123814 SESE 2013-08-13 (k number procode)
Predicate lineage
K123814 — cites (transitively): K060874 (d1), K111097 (d1) — cited as predicate by K150488, K163669, K191698, K201391, K254154
Lineage extracted from public 510(k) summary text (heuristic).