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BIOMET HIP SYSTEM
Model 163130 · Biomet Orthopedics, LLC · DI 00880304001480
JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal · Class II · 21 CFR 888.3360
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
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353
UDILibrary device dossier · generated 2026-09-15 · 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
3.27
2019-02
0
2.82
2019-03
0
3.08
2019-04
0
2.89
2019-05
0
2.26
2019-06
0
1.96
2019-07
0
1.99
2019-08
0
2.27
2019-09
0
2.54
2019-10
0
2.75
2019-11
0
2.29
2019-12
0
2.66
2020-01
0
3.05
2020-02
0
2.72
2020-03
0
3.49
2020-04
0
2.49
2020-05
0
2.61
2020-06
0
2.32
2020-07
0
3
2020-08
0
2.72
2020-09
0
3.04
2020-10
0
3.17
2020-11
0
2.98
2020-12
0
3.18
2021-01
0
3.1
2021-02
0
2.56
2021-03
0
2.35
2021-04
0
2.36
2021-05
0
2.73
2021-06
0
2.91
2021-07
0
2.84
2021-08
0
2.77
2021-09
0
2.93
2021-10
0
2.52
2021-11
0
2.64
2021-12
0
2.8
2022-01
0
2.51
2022-02
0
2.77
2022-03
0
2.52
2022-04
0
2.62
2022-05
0
2.49
2022-06
0
2.49
2022-07
0
2.33
2022-08
0
2.43
2022-09
0
2.36
2022-10
0
2.44
2022-11
0
2.47
2022-12
0
2.5
2023-01
0
2.4
2023-02
0
2.32
2023-03
0
2.58
2023-04
0
2.41
2023-05
0
2.45
2023-06
0
2.48
2023-07
0
2.26
2023-08
0
2.15
2023-09
0
2.12
2023-10
0
1.77
2023-11
0
1.75
2023-12
0
1.82
2024-01
0
1.84
2024-02
0
2.18
2024-03
0
2.04
2024-04
0
1.86
2024-05
0
2.21
2024-06
0
2
2024-07
0
1.82
2024-08
0
1.98
2024-09
0
2.17
2024-10
0
1.89
2024-11
0
1.88
2024-12
0
1.66
2025-01
0
2.02
2025-02
0
1.61
2025-03
0
1.81
2025-04
0
1.91
2025-05
0
1.83
2025-06
0
1.92
2025-07
0
1.89
2025-08
0
1.84
2025-09
0
1.85
2025-10
0
1.82
2025-11
0
1.94
2025-12
0
2.01
2026-01
0
2.13
2026-02
0
1.77
2026-03
0
2.11
2026-04
0
1.96
2026-05
0
1.93
2026-06
0
1.82
This device (reports/month)Average device in JDG, JDI, KRO, LPH, LZO (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K942479 — cited as predicate by K193546
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