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Comprehensive® Reverse Shoulder

Model 180552 · Biomet Orthopedics, LLC · DI 00880304677159

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

PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660

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 (50)

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: 43 · Malfunction: 6 · Death: 1

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	1.81
2019-02	0	1.75
2019-03	0	1.68
2019-04	0	1.92
2019-05	0	2.1
2019-06	0	1.86
2019-07	0	1.67
2019-08	0	2.15
2019-09	0	1.67
2019-10	0	1.89
2019-11	1	1.61
2019-12	1	1.79
2020-01	0	1.88
2020-02	0	2.01
2020-03	1	2.1
2020-04	0	1.67
2020-05	0	1.68
2020-06	3	1.99
2020-07	0	2.2
2020-08	0	1.82
2020-09	2	2
2020-10	2	2.22
2020-11	0	1.92
2020-12	0	1.84
2021-01	0	2.1
2021-02	1	1.86
2021-03	0	2.02
2021-04	0	2
2021-05	0	1.85
2021-06	0	1.81
2021-07	0	2.04
2021-08	0	2.22
2021-09	0	1.87
2021-10	0	2.15
2021-11	1	2.04
2021-12	1	2.43
2022-01	0	2.51
2022-02	0	2.33
2022-03	0	2.33
2022-04	0	2.35
2022-05	0	1.98
2022-06	2	2.23
2022-07	0	2.14
2022-08	2	2.16
2022-09	1	1.97
2022-10	0	1.92
2022-11	0	2.09
2022-12	0	1.98
2023-01	0	1.78
2023-02	0	1.9
2023-03	2	1.89
2023-04	0	2.11
2023-05	1	1.97
2023-06	3	2.14
2023-07	0	2.01
2023-08	1	1.67
2023-09	1	1.52
2023-10	1	1.57
2023-11	1	1.67
2023-12	0	1.41
2024-01	0	1.78
2024-02	0	1.89
2024-03	0	1.65
2024-04	3	1.81
2024-05	0	1.67
2024-06	1	1.83
2024-07	0	1.61
2024-08	0	1.66
2024-09	0	1.67
2024-10	2	1.68
2024-11	0	1.6
2024-12	1	1.63
2025-01	0	1.71
2025-02	1	1.62
2025-03	1	1.84
2025-04	0	1.73
2025-05	3	1.86
2025-06	0	1.89
2025-07	3	1.71
2025-08	0	1.64
2025-09	1	1.44
2025-10	0	1.6
2025-11	0	1.71
2025-12	2	2.19
2026-01	0	1.89
2026-02	1	1.71
2026-03	0	1.73
2026-04	2	1.72
2026-05	0	1.69
2026-06	1	1.69

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

Regulatory clearances

None linked in the loaded window.

Predicate lineage

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

K130390 — cited as predicate by K200368, K211729, K230831

K132239 — cited as predicate by K193373, K200368

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

Manufacturer compliance record — Biomet Orthopedics, LLC

Nothing in the loaded window.