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Comprehensive® Shoulder System

Model 405306 · Biomet Orthopedics, LLC · DI 00887868504419

HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · Class II · 21 CFR 888.3690

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

PAO — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented · 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 (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	1.51
2019-03	0	1.61
2019-04	0	1.65
2019-05	0	1.83
2019-06	0	1.82
2019-07	0	1.42
2019-08	0	1.98
2019-09	0	1.54
2019-10	0	1.79
2019-11	0	1.53
2019-12	0	1.75
2020-01	0	1.87
2020-02	0	2.07
2020-03	0	1.64
2020-04	0	1.59
2020-05	0	1.56
2020-06	0	1.91
2020-07	0	1.94
2020-08	0	1.8
2020-09	0	2
2020-10	0	2.06
2020-11	0	1.86
2020-12	0	1.78
2021-01	0	1.88
2021-02	0	1.8
2021-03	0	1.93
2021-04	0	1.89
2021-05	0	1.65
2021-06	0	1.54
2021-07	0	1.94
2021-08	0	2.15
2021-09	0	1.7
2021-10	0	1.85
2021-11	0	1.93
2021-12	0	1.93
2022-01	0	2.12
2022-02	0	2.14
2022-03	0	1.81
2022-04	0	2.03
2022-05	0	1.82
2022-06	0	2.09
2022-07	0	2.09
2022-08	0	1.95
2022-09	0	1.85
2022-10	0	1.73
2022-11	0	1.91
2022-12	0	1.76
2023-01	0	1.7
2023-02	0	1.74
2023-03	0	1.81
2023-04	0	1.88
2023-05	0	1.87
2023-06	0	2.04
2023-07	0	1.93
2023-08	0	1.56
2023-09	0	1.41
2023-10	0	1.51
2023-11	0	1.57
2023-12	0	1.36
2024-01	0	1.71
2024-02	0	1.68
2024-03	0	1.55
2024-04	0	1.71
2024-05	0	1.57
2024-06	0	1.82
2024-07	0	1.52
2024-08	0	1.62
2024-09	0	1.58
2024-10	0	1.59
2024-11	0	1.52
2024-12	0	1.55
2025-01	0	1.66
2025-02	0	1.52
2025-03	0	1.73
2025-04	0	1.62
2025-05	0	1.75
2025-06	0	1.76
2025-07	0	1.62
2025-08	0	1.57
2025-09	0	1.41
2025-10	0	1.51
2025-11	0	1.71
2025-12	0	2.12
2026-01	0	1.81
2026-02	0	1.66
2026-03	0	1.64
2026-04	0	1.69
2026-05	0	1.59
2026-06	0	1.61

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

Regulatory clearances

None linked in the loaded window.

Predicate lineage

K060692 — cited as predicate by K102924, K120794, K131135, K131633, K162726, K173824, K182516, K183039, K191963, K193038, K202024, K202716, K210899, K212737, K241817

K080642 — cited as predicate by K162726, K170711, K172456, K172502, K173411, K181611, K193373, K200368, K202024, K210533, K210861, K231445, K233148, K233482, K252404

K193038 — cites (transitively): K033506 (d1), K040610 (d1), K060692 (d1), K060694 (d1), K060716 (d1), K140390 (d1), K140652 (d1), K030710 (d2), K915596 (d2) — cited as predicate by K212435, K213856, K214001, K250848

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

Manufacturer compliance record — Biomet Orthopedics, LLC

Nothing in the loaded window.