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Model 267353 · FOURNITURES HOSPITALIERES INDUSTRIE · DI 03661489673535

KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660

KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650

MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3670

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 (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	1.72
2019-02	0	1.53
2019-03	0	1.59
2019-04	0	1.71
2019-05	0	1.84
2019-06	0	1.84
2019-07	0	1.45
2019-08	0	1.96
2019-09	0	1.51
2019-10	0	1.84
2019-11	0	1.53
2019-12	0	1.8
2020-01	0	1.85
2020-02	0	2.06
2020-03	0	1.74
2020-04	0	1.59
2020-05	0	1.52
2020-06	0	1.96
2020-07	0	1.9
2020-08	0	1.79
2020-09	0	2.02
2020-10	0	2.17
2020-11	0	1.88
2020-12	0	1.79
2021-01	0	1.86
2021-02	0	1.72
2021-03	0	1.88
2021-04	0	1.79
2021-05	0	1.62
2021-06	0	1.56
2021-07	0	1.91
2021-08	0	2.14
2021-09	0	1.67
2021-10	0	1.81
2021-11	0	1.91
2021-12	0	1.93
2022-01	0	2.06
2022-02	0	2.14
2022-03	0	1.85
2022-04	0	2.02
2022-05	0	1.78
2022-06	0	2.14
2022-07	0	2.04
2022-08	0	1.98
2022-09	0	1.82
2022-10	0	1.71
2022-11	0	1.97
2022-12	0	1.77
2023-01	0	1.67
2023-02	0	1.83
2023-03	0	1.8
2023-04	0	1.87
2023-05	0	1.87
2023-06	0	2.08
2023-07	0	1.99
2023-08	0	1.63
2023-09	0	1.47
2023-10	0	1.51
2023-11	0	1.61
2023-12	0	1.38
2024-01	0	1.84
2024-02	0	1.82
2024-03	0	1.63
2024-04	0	1.75
2024-05	0	1.67
2024-06	0	1.87
2024-07	0	1.59
2024-08	0	1.63
2024-09	0	1.69
2024-10	0	1.62
2024-11	0	1.6
2024-12	0	1.64
2025-01	0	1.7
2025-02	0	1.58
2025-03	0	1.78
2025-04	0	1.71
2025-05	0	1.85
2025-06	0	1.82
2025-07	0	1.63
2025-08	0	1.61
2025-09	0	1.42
2025-10	0	1.55
2025-11	0	1.69
2025-12	0	2.11
2026-01	0	1.83
2026-02	0	1.66
2026-03	0	1.68
2026-04	0	1.7
2026-05	0	1.64
2026-06	0	1.6

This device (reports/month)Average device in KWS, KWT, MBF (reports/device/month)

Regulatory clearances

None linked in the loaded window.

Predicate lineage

K162068 — cites (transitively): K030710 (d1), K093599 (d1), K112193 (d1), K142778 (d1), K042021 (d2), K061454 (d2), K992065 (d2), K103251 (d2) — cited as predicate by K171789, K182039, K202024, K220758

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — FOURNITURES HOSPITALIERES INDUSTRIE

Nothing in the loaded window.