SMR Shoulder
Model 9013.52.014 · LIMACORPORATE SPA · DI 08033390152020
KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.68 |
| 2019-02 | 0 | 1.59 |
| 2019-03 | 0 | 1.68 |
| 2019-04 | 0 | 1.52 |
| 2019-05 | 0 | 1.76 |
| 2019-06 | 0 | 1.87 |
| 2019-07 | 0 | 1.41 |
| 2019-08 | 0 | 1.97 |
| 2019-09 | 0 | 1.48 |
| 2019-10 | 0 | 1.8 |
| 2019-11 | 0 | 1.62 |
| 2019-12 | 0 | 1.74 |
| 2020-01 | 0 | 1.89 |
| 2020-02 | 0 | 2.15 |
| 2020-03 | 0 | 1.76 |
| 2020-04 | 0 | 1.72 |
| 2020-05 | 0 | 1.43 |
| 2020-06 | 0 | 1.8 |
| 2020-07 | 0 | 1.91 |
| 2020-08 | 0 | 1.63 |
| 2020-09 | 0 | 1.92 |
| 2020-10 | 0 | 2.1 |
| 2020-11 | 0 | 1.85 |
| 2020-12 | 0 | 1.82 |
| 2021-01 | 0 | 1.95 |
| 2021-02 | 0 | 1.82 |
| 2021-03 | 0 | 1.98 |
| 2021-04 | 0 | 1.76 |
| 2021-05 | 0 | 1.76 |
| 2021-06 | 0 | 1.63 |
| 2021-07 | 0 | 1.87 |
| 2021-08 | 0 | 2.03 |
| 2021-09 | 0 | 1.66 |
| 2021-10 | 0 | 1.71 |
| 2021-11 | 0 | 1.97 |
| 2021-12 | 0 | 1.93 |
| 2022-01 | 0 | 2.04 |
| 2022-02 | 0 | 2.04 |
| 2022-03 | 0 | 1.73 |
| 2022-04 | 0 | 2.04 |
| 2022-05 | 0 | 1.88 |
| 2022-06 | 0 | 2.01 |
| 2022-07 | 0 | 2.05 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 1.84 |
| 2022-10 | 0 | 1.87 |
| 2022-11 | 0 | 2.02 |
| 2022-12 | 0 | 1.82 |
| 2023-01 | 0 | 1.72 |
| 2023-02 | 0 | 1.94 |
| 2023-03 | 0 | 1.93 |
| 2023-04 | 0 | 1.92 |
| 2023-05 | 0 | 2 |
| 2023-06 | 0 | 2.26 |
| 2023-07 | 0 | 2.07 |
| 2023-08 | 0 | 1.67 |
| 2023-09 | 0 | 1.51 |
| 2023-10 | 0 | 1.56 |
| 2023-11 | 0 | 1.61 |
| 2023-12 | 0 | 1.41 |
| 2024-01 | 0 | 1.99 |
| 2024-02 | 0 | 1.76 |
| 2024-03 | 0 | 1.68 |
| 2024-04 | 0 | 1.77 |
| 2024-05 | 0 | 1.72 |
| 2024-06 | 0 | 1.9 |
| 2024-07 | 0 | 1.6 |
| 2024-08 | 0 | 1.7 |
| 2024-09 | 0 | 1.71 |
| 2024-10 | 0 | 1.61 |
| 2024-11 | 0 | 1.58 |
| 2024-12 | 0 | 1.63 |
| 2025-01 | 0 | 1.72 |
| 2025-02 | 0 | 1.56 |
| 2025-03 | 0 | 1.84 |
| 2025-04 | 0 | 1.63 |
| 2025-05 | 0 | 1.75 |
| 2025-06 | 0 | 1.83 |
| 2025-07 | 0 | 1.71 |
| 2025-08 | 0 | 1.53 |
| 2025-09 | 0 | 1.51 |
| 2025-10 | 0 | 1.62 |
| 2025-11 | 0 | 1.71 |
| 2025-12 | 0 | 2.11 |
| 2026-01 | 0 | 1.87 |
| 2026-02 | 0 | 1.8 |
| 2026-03 | 0 | 1.75 |
| 2026-04 | 0 | 1.7 |
| 2026-05 | 0 | 1.75 |
| 2026-06 | 0 | 1.68 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K110598 — cited as predicate by K142139, K153602, K161189, K163397, K170893, K172054, K172456, K183042, K190286, K190911, K191963, K193560, K200368, K201905, K212569, K212800, K212992, K220452, K220792, K221758, K230315, K231112, K233408, K241143, K242813, K243826, K243955, K251184, K251558, K260802
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — LIMACORPORATE SPA
Nothing in the loaded window.