Print-ready dossier — use your browser's print dialog to save as PDF.
MASTERSL
Model Uncemented Stem · LIMACORPORATE SPA · DI 08033390083430
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390
KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer · Class II · 21 CFR 888.3310
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 2026-09-11 · 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
3.02
2019-02
0
2.57
2019-03
0
2.92
2019-04
0
2.75
2019-05
0
2.17
2019-06
0
1.85
2019-07
0
1.87
2019-08
0
2.13
2019-09
0
2.39
2019-10
0
2.59
2019-11
0
2.14
2019-12
0
2.47
2020-01
0
2.87
2020-02
0
2.54
2020-03
0
3.2
2020-04
0
2.26
2020-05
0
2.24
2020-06
0
2.05
2020-07
0
2.51
2020-08
0
2.02
2020-09
0
2.54
2020-10
0
2.52
2020-11
0
2.32
2020-12
0
2.34
2021-01
0
2.47
2021-02
0
2.06
2021-03
0
2.05
2021-04
0
2.04
2021-05
0
2
2021-06
0
2.48
2021-07
0
2.33
2021-08
0
2.27
2021-09
0
2.38
2021-10
0
2.2
2021-11
0
2.07
2021-12
0
2.32
2022-01
0
2.08
2022-02
0
2.08
2022-03
0
2.16
2022-04
0
2.16
2022-05
0
2.12
2022-06
0
2.22
2022-07
0
2.07
2022-08
0
2.14
2022-09
0
2.16
2022-10
0
2.12
2022-11
0
2.21
2022-12
0
2.19
2023-01
0
2.28
2023-02
0
2.1
2023-03
0
2.32
2023-04
0
2.21
2023-05
0
2.16
2023-06
0
2.2
2023-07
0
2.07
2023-08
0
1.93
2023-09
0
1.93
2023-10
0
1.64
2023-11
0
1.61
2023-12
0
1.7
2024-01
0
1.72
2024-02
0
2.03
2024-03
0
1.91
2024-04
0
1.72
2024-05
0
1.99
2024-06
0
1.85
2024-07
0
1.71
2024-08
0
1.82
2024-09
0
1.96
2024-10
0
1.75
2024-11
0
1.73
2024-12
0
1.55
2025-01
0
1.89
2025-02
0
1.51
2025-03
0
1.78
2025-04
0
1.81
2025-05
0
1.69
2025-06
0
1.82
2025-07
0
1.82
2025-08
0
1.67
2025-09
0
1.71
2025-10
0
1.72
2025-11
0
1.78
2025-12
0
1.87
2026-01
0
1.97
2026-02
0
1.62
2026-03
0
1.91
2026-04
0
1.88
2026-05
0
1.68
2026-06
0
1.71
This device (reports/month)Average device in JDI, KWY, KWZ, LPH, LZO (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K140975 — cites (transitively): K972791 (d1) — cited as predicate by K150855, K243809
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — LIMACORPORATE SPA