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Ceramic Femoral Head BIOLOX® Delta 12/14M
Model 1203-5228 · UNITED ORTHOPEDIC CORP. · DI 04712771494921
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3360
MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353
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
2.98
2019-02
0
2.58
2019-03
0
2.94
2019-04
0
2.75
2019-05
0
2.15
2019-06
0
1.82
2019-07
0
1.84
2019-08
0
2.18
2019-09
0
2.43
2019-10
0
2.65
2019-11
0
2.23
2019-12
0
2.45
2020-01
0
2.75
2020-02
0
2.55
2020-03
0
3.24
2020-04
0
2.27
2020-05
0
2.12
2020-06
0
2.1
2020-07
0
2.54
2020-08
0
1.99
2020-09
0
2.48
2020-10
0
2.43
2020-11
0
2.34
2020-12
0
2.3
2021-01
0
2.49
2021-02
0
2
2021-03
0
2
2021-04
0
2.1
2021-05
0
1.9
2021-06
0
2.56
2021-07
0
2.28
2021-08
0
2.32
2021-09
0
2.37
2021-10
0
2.17
2021-11
0
2.02
2021-12
0
2.26
2022-01
0
2.04
2022-02
0
1.89
2022-03
0
2.19
2022-04
0
2.1
2022-05
0
2.06
2022-06
0
2.29
2022-07
0
2.08
2022-08
0
2.22
2022-09
0
2.21
2022-10
0
2.14
2022-11
0
2.22
2022-12
0
2.09
2023-01
0
2.29
2023-02
0
2.18
2023-03
0
2.45
2023-04
0
2.39
2023-05
0
2.23
2023-06
0
2.37
2023-07
0
2.23
2023-08
0
2.1
2023-09
0
2.1
2023-10
0
1.75
2023-11
0
1.67
2023-12
0
1.77
2024-01
0
1.8
2024-02
0
2.13
2024-03
0
2.11
2024-04
0
1.88
2024-05
0
2.3
2024-06
0
2.11
2024-07
0
1.8
2024-08
0
2.07
2024-09
0
2.22
2024-10
0
1.92
2024-11
0
1.76
2024-12
0
1.61
2025-01
0
1.92
2025-02
0
1.56
2025-03
0
1.81
2025-04
0
1.82
2025-05
0
1.72
2025-06
0
1.84
2025-07
0
1.85
2025-08
0
1.7
2025-09
0
1.74
2025-10
0
1.69
2025-11
0
1.74
2025-12
0
1.87
2026-01
0
1.92
2026-02
0
1.64
2026-03
0
1.97
2026-04
0
1.8
2026-05
0
1.62
2026-06
0
1.78
This device (reports/month)Average device in LPH, LWJ, MEH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K103497 — cited as predicate by K112463, K122185, K123550, K151316, K163441, K221675, K242249, K242315, K243466
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — UNITED ORTHOPEDIC CORP.
VAI 2026-03-12 United Orthopedic Corp. · 0 citations
VAI 2026-03-12 United Orthopedic Corp. · 0 citations