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U2 Femoral component, CR, porous coated
Model 2103-1230 · UNITED ORTHOPEDIC CORP. · DI 04712602345446
MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer · Class II · 21 CFR 888.3565
UDILibrary device dossier · generated 2026-09-12 · 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 (3)
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.
Injury: 3
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
1.18
2019-02
0
1.28
2019-03
0
1.31
2019-04
0
1.37
2019-05
0
1.34
2019-06
0
1.31
2019-07
0
1.49
2019-08
0
1.27
2019-09
0
1.32
2019-10
0
1.17
2019-11
0
1.4
2019-12
0
1.33
2020-01
0
1.37
2020-02
0
1.2
2020-03
0
1.42
2020-04
0
1.24
2020-05
0
1.07
2020-06
0
1.38
2020-07
0
1.49
2020-08
0
1.3
2020-09
0
1.35
2020-10
0
1.28
2020-11
0
1.33
2020-12
0
1.19
2021-01
0
1.28
2021-02
0
1.4
2021-03
0
1.45
2021-04
0
1.3
2021-05
0
1.21
2021-06
0
1.35
2021-07
0
1.28
2021-08
0
1.33
2021-09
0
1.27
2021-10
0
1.27
2021-11
0
1.29
2021-12
0
1.35
2022-01
0
1.23
2022-02
0
1.53
2022-03
0
1.34
2022-04
0
1.32
2022-05
0
1.2
2022-06
0
1.32
2022-07
0
1.28
2022-08
0
1.3
2022-09
0
1.27
2022-10
0
1.23
2022-11
0
1.33
2022-12
0
1.27
2023-01
0
1.11
2023-02
0
1.24
2023-03
0
1.19
2023-04
0
1.38
2023-05
0
1.36
2023-06
0
1.4
2023-07
0
1.13
2023-08
0
1.13
2023-09
0
1.11
2023-10
0
1.1
2023-11
0
1.22
2023-12
0
1.17
2024-01
0
1.14
2024-02
0
1.18
2024-03
0
1.29
2024-04
0
1.27
2024-05
0
1.14
2024-06
0
1.24
2024-07
0
1.17
2024-08
0
1.32
2024-09
0
1.3
2024-10
0
1.33
2024-11
0
1.15
2024-12
0
1.22
2025-01
0
1.29
2025-02
0
1.24
2025-03
0
1.11
2025-04
0
1.26
2025-05
0
1.29
2025-06
0
1.27
2025-07
0
1.23
2025-08
0
1.35
2025-09
0
1.16
2025-10
0
1.24
2025-11
0
1.27
2025-12
0
1.35
2026-01
0
1.32
2026-02
0
1.27
2026-03
0
1.26
2026-04
0
1.25
2026-05
1
1.23
2026-06
2
1.26
This device (reports/month)Average device in MBH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K140075 — cites (transitively): K030612 (d1) — cited as predicate by K150832, K152430, K221705, K243656
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