Print-ready dossier — use your browser's print dialog to save as PDF.
32mm Glenosphere and Humeral Cup
Model 102-0803 · FX SOLUTIONS · DI 03701037309353
HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · Class II · 21 CFR 888.3690
KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650
PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660
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 (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
1.91
2019-02
0
1.78
2019-03
0
1.66
2019-04
0
2.06
2019-05
0
2.22
2019-06
0
1.85
2019-07
0
1.74
2019-08
0
2.27
2019-09
0
1.78
2019-10
0
1.89
2019-11
0
1.71
2019-12
0
1.8
2020-01
0
2
2020-02
0
2.08
2020-03
0
2.14
2020-04
0
1.74
2020-05
0
1.84
2020-06
0
2.08
2020-07
0
2.29
2020-08
0
1.94
2020-09
0
2.06
2020-10
0
2.19
2020-11
0
1.96
2020-12
0
1.86
2021-01
0
2.21
2021-02
0
2.04
2021-03
0
2.14
2021-04
0
2.15
2021-05
0
1.96
2021-06
0
1.86
2021-07
0
2.24
2021-08
0
2.37
2021-09
0
2.08
2021-10
0
2.41
2021-11
0
2.12
2021-12
0
2.65
2022-01
0
2.77
2022-02
0
2.62
2022-03
0
2.74
2022-04
0
2.56
2022-05
0
2.15
2022-06
0
2.44
2022-07
0
2.38
2022-08
0
2.3
2022-09
0
2.1
2022-10
0
2.08
2022-11
0
2.09
2022-12
0
2.14
2023-01
0
1.9
2023-02
0
1.91
2023-03
0
2.02
2023-04
0
2.22
2023-05
0
2.08
2023-06
0
2.18
2023-07
0
2.03
2023-08
0
1.72
2023-09
0
1.52
2023-10
0
1.62
2023-11
0
1.66
2023-12
0
1.43
2024-01
0
1.61
2024-02
0
1.84
2024-03
0
1.64
2024-04
0
1.88
2024-05
0
1.6
2024-06
0
1.87
2024-07
0
1.55
2024-08
0
1.7
2024-09
0
1.67
2024-10
0
1.75
2024-11
0
1.64
2024-12
0
1.65
2025-01
0
1.71
2025-02
1
1.67
2025-03
0
1.87
2025-04
0
1.82
2025-05
0
1.84
2025-06
1
1.89
2025-07
0
1.71
2025-08
0
1.7
2025-09
0
1.46
2025-10
0
1.61
2025-11
1
1.77
2025-12
0
2.14
2026-01
0
1.85
2026-02
0
1.77
2026-03
0
1.73
2026-04
0
1.73
2026-05
0
1.68
2026-06
0
1.76
This device (reports/month)Average device in HSD, KWT, PHX (reports/device/month)
Regulatory clearances
K192206 SESE 2019-10-08 (k number procode)
Predicate lineage
K192206 — cited as predicate by K193394
Lineage extracted from public 510(k) summary text (heuristic).