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BIO-CLAD ALL POLY CUP SYSTEM
Model 163453 · Biomet Orthopedics, LLC · DI 00880304255791
JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal · Class II · 21 CFR 888.3360
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
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
3.72
2019-02
0
3.19
2019-03
0
3.52
2019-04
0
3.29
2019-05
0
2.51
2019-06
0
2.12
2019-07
0
2.14
2019-08
0
2.45
2019-09
0
2.97
2019-10
0
3.28
2019-11
0
2.63
2019-12
0
2.99
2020-01
0
3.39
2020-02
0
3.03
2020-03
0
3.9
2020-04
0
2.73
2020-05
0
2.84
2020-06
0
2.83
2020-07
0
3.76
2020-08
0
3.72
2020-09
0
3.69
2020-10
0
3.94
2020-11
0
3.99
2020-12
0
4.48
2021-01
0
4.25
2021-02
0
3.24
2021-03
0
2.8
2021-04
0
2.9
2021-05
0
3.7
2021-06
0
3.66
2021-07
0
3.4
2021-08
0
3.63
2021-09
0
3.69
2021-10
0
2.94
2021-11
0
3.27
2021-12
0
3.33
2022-01
0
3.02
2022-02
0
3.15
2022-03
0
3.17
2022-04
0
3.17
2022-05
0
2.88
2022-06
0
2.95
2022-07
0
2.61
2022-08
0
2.77
2022-09
0
2.6
2022-10
0
2.81
2022-11
0
2.61
2022-12
0
2.75
2023-01
0
2.71
2023-02
0
2.67
2023-03
0
3.07
2023-04
0
2.77
2023-05
0
2.72
2023-06
0
2.68
2023-07
0
2.37
2023-08
0
2.24
2023-09
0
2.15
2023-10
0
1.97
2023-11
0
1.87
2023-12
0
1.93
2024-01
0
1.97
2024-02
0
2.4
2024-03
0
2.14
2024-04
0
2
2024-05
0
2.2
2024-06
0
2.14
2024-07
0
1.92
2024-08
0
2.09
2024-09
0
2.35
2024-10
0
2.05
2024-11
0
2.06
2024-12
0
1.72
2025-01
0
2.16
2025-02
0
1.71
2025-03
0
1.93
2025-04
0
1.97
2025-05
0
1.97
2025-06
0
2.03
2025-07
0
2.04
2025-08
0
1.9
2025-09
0
1.89
2025-10
0
1.88
2025-11
0
1.89
2025-12
0
2.07
2026-01
0
2.13
2026-02
0
1.77
2026-03
0
2.05
2026-04
0
1.97
2026-05
0
1.85
2026-06
0
1.89
This device (reports/month)Average device in JDG, LPH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K926107 — cited as predicate by K111863
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC