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AGC KNEE SYSTEM
Model 155360 · Biomet Orthopedics, LLC · DI 00880304246157
HRY — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3530
JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560
UDILibrary device dossier · generated 2026-09-11 · 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
2.01
2019-02
0
2.05
2019-03
0
1.66
2019-04
0
1.98
2019-05
0
1.81
2019-06
0
2.17
2019-07
0
2.01
2019-08
0
2.2
2019-09
0
1.96
2019-10
0
2.35
2019-11
0
2.93
2019-12
0
2.41
2020-01
0
2.33
2020-02
0
2.74
2020-03
0
2.3
2020-04
0
2.2
2020-05
0
1.81
2020-06
0
2.29
2020-07
0
2.85
2020-08
0
2.95
2020-09
0
2.45
2020-10
0
3.15
2020-11
0
3.18
2020-12
0
3.49
2021-01
0
2.8
2021-02
0
2.85
2021-03
0
2.61
2021-04
0
2.45
2021-05
0
2.8
2021-06
0
2.5
2021-07
0
2.5
2021-08
0
2.13
2021-09
0
2.74
2021-10
0
2.12
2021-11
0
2.53
2021-12
0
2.58
2022-01
0
2.24
2022-02
0
2.68
2022-03
0
2.4
2022-04
0
2.36
2022-05
0
2.87
2022-06
0
2.18
2022-07
0
2.33
2022-08
0
2.23
2022-09
0
2.36
2022-10
0
2.41
2022-11
0
2.37
2022-12
0
2.04
2023-01
0
2.21
2023-02
0
2.3
2023-03
0
2.26
2023-04
0
2.38
2023-05
0
2.46
2023-06
0
2.38
2023-07
0
2.03
2023-08
0
1.76
2023-09
0
1.77
2023-10
0
1.67
2023-11
0
1.79
2023-12
0
1.73
2024-01
0
1.67
2024-02
0
1.8
2024-03
0
1.84
2024-04
0
1.72
2024-05
0
1.91
2024-06
0
2.01
2024-07
0
1.91
2024-08
0
2.33
2024-09
0
2.03
2024-10
0
2.01
2024-11
0
2
2024-12
0
2.15
2025-01
0
2.32
2025-02
0
1.85
2025-03
0
1.88
2025-04
0
1.71
2025-05
0
1.74
2025-06
0
1.82
2025-07
0
1.68
2025-08
0
1.65
2025-09
0
1.71
2025-10
0
1.5
2025-11
0
1.73
2025-12
0
1.7
2026-01
0
1.56
2026-02
0
1.58
2026-03
0
2.03
2026-04
0
1.77
2026-05
0
1.77
2026-06
0
1.72
This device (reports/month)Average device in HRY, JWH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K921182 — cited as predicate by K110362, K171054
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC