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Biomet® Hip System
Model 163625 · Biomet Orthopedics, LLC · DI 00887868308901
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3510
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
UDILibrary device dossier · generated 2026-09-13 · 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
3.54
2019-02
0
2.98
2019-03
0
3.27
2019-04
0
3.03
2019-05
0
2.36
2019-06
0
2.02
2019-07
0
2.15
2019-08
0
2.33
2019-09
0
2.75
2019-10
0
2.91
2019-11
0
2.36
2019-12
0
2.75
2020-01
0
3.08
2020-02
0
2.83
2020-03
0
3.64
2020-04
0
2.54
2020-05
0
2.63
2020-06
0
2.24
2020-07
0
2.74
2020-08
0
2.16
2020-09
0
2.73
2020-10
0
2.82
2020-11
0
2.53
2020-12
0
2.47
2021-01
0
2.6
2021-02
0
2.18
2021-03
0
2.21
2021-04
0
2.22
2021-05
0
2.18
2021-06
0
2.73
2021-07
0
2.56
2021-08
0
2.43
2021-09
0
2.53
2021-10
0
2.28
2021-11
0
2.42
2021-12
0
2.64
2022-01
0
2.27
2022-02
0
2.48
2022-03
0
2.3
2022-04
0
2.4
2022-05
0
2.2
2022-06
0
2.46
2022-07
0
2.22
2022-08
0
2.35
2022-09
0
2.25
2022-10
0
2.27
2022-11
0
2.44
2022-12
0
2.44
2023-01
0
2.24
2023-02
0
2.26
2023-03
0
2.56
2023-04
0
2.36
2023-05
0
2.4
2023-06
0
2.46
2023-07
0
2.23
2023-08
0
2.19
2023-09
0
2.15
2023-10
0
1.72
2023-11
0
1.69
2023-12
0
1.77
2024-01
0
1.83
2024-02
0
2.12
2024-03
0
2.04
2024-04
0
1.79
2024-05
0
2.18
2024-06
0
1.97
2024-07
0
1.81
2024-08
0
1.89
2024-09
0
2.22
2024-10
0
1.88
2024-11
0
1.79
2024-12
0
1.6
2025-01
0
1.93
2025-02
0
1.56
2025-03
0
1.77
2025-04
0
1.85
2025-05
0
1.74
2025-06
0
1.86
2025-07
0
1.85
2025-08
0
1.76
2025-09
0
1.9
2025-10
0
1.77
2025-11
0
1.94
2025-12
0
1.99
2026-01
0
2.15
2026-02
0
1.72
2026-03
0
2.17
2026-04
0
1.87
2026-05
0
1.88
2026-06
0
1.77
This device (reports/month)Average device in JDI, KRO, LPH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K974558 — cited as predicate by K131684, K141653, K150522, K192683, K200959
K990830 — cited as predicate by K131684, K141653, K192683, K200959
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC