SMR Shoulder
Model Liner · LIMACORPORATE SPA · DI 08033390086486
KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660
KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650
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 | 1.74 |
| 2019-02 | 0 | 1.55 |
| 2019-03 | 0 | 1.6 |
| 2019-04 | 0 | 1.72 |
| 2019-05 | 0 | 1.87 |
| 2019-06 | 0 | 1.88 |
| 2019-07 | 0 | 1.47 |
| 2019-08 | 0 | 2 |
| 2019-09 | 0 | 1.52 |
| 2019-10 | 0 | 1.86 |
| 2019-11 | 0 | 1.58 |
| 2019-12 | 0 | 1.8 |
| 2020-01 | 0 | 1.87 |
| 2020-02 | 0 | 2.13 |
| 2020-03 | 0 | 1.77 |
| 2020-04 | 0 | 1.67 |
| 2020-05 | 0 | 1.55 |
| 2020-06 | 0 | 1.98 |
| 2020-07 | 0 | 1.91 |
| 2020-08 | 0 | 1.79 |
| 2020-09 | 0 | 2.01 |
| 2020-10 | 0 | 2.2 |
| 2020-11 | 0 | 1.94 |
| 2020-12 | 0 | 1.84 |
| 2021-01 | 0 | 1.95 |
| 2021-02 | 0 | 1.74 |
| 2021-03 | 0 | 1.93 |
| 2021-04 | 0 | 1.82 |
| 2021-05 | 0 | 1.66 |
| 2021-06 | 0 | 1.58 |
| 2021-07 | 0 | 1.97 |
| 2021-08 | 0 | 2.12 |
| 2021-09 | 0 | 1.72 |
| 2021-10 | 0 | 1.81 |
| 2021-11 | 0 | 1.93 |
| 2021-12 | 0 | 2.02 |
| 2022-01 | 0 | 2.08 |
| 2022-02 | 0 | 2.17 |
| 2022-03 | 0 | 1.87 |
| 2022-04 | 0 | 2.07 |
| 2022-05 | 0 | 1.83 |
| 2022-06 | 0 | 2.17 |
| 2022-07 | 0 | 2.1 |
| 2022-08 | 0 | 2.02 |
| 2022-09 | 0 | 1.88 |
| 2022-10 | 0 | 1.8 |
| 2022-11 | 0 | 2 |
| 2022-12 | 0 | 1.86 |
| 2023-01 | 0 | 1.72 |
| 2023-02 | 0 | 1.87 |
| 2023-03 | 0 | 1.85 |
| 2023-04 | 0 | 1.86 |
| 2023-05 | 0 | 1.93 |
| 2023-06 | 0 | 2.13 |
| 2023-07 | 0 | 2.05 |
| 2023-08 | 0 | 1.67 |
| 2023-09 | 0 | 1.5 |
| 2023-10 | 0 | 1.53 |
| 2023-11 | 0 | 1.62 |
| 2023-12 | 0 | 1.4 |
| 2024-01 | 0 | 1.9 |
| 2024-02 | 0 | 1.83 |
| 2024-03 | 0 | 1.67 |
| 2024-04 | 0 | 1.8 |
| 2024-05 | 0 | 1.71 |
| 2024-06 | 0 | 1.89 |
| 2024-07 | 0 | 1.6 |
| 2024-08 | 0 | 1.68 |
| 2024-09 | 0 | 1.74 |
| 2024-10 | 0 | 1.65 |
| 2024-11 | 0 | 1.65 |
| 2024-12 | 0 | 1.7 |
| 2025-01 | 0 | 1.74 |
| 2025-02 | 0 | 1.63 |
| 2025-03 | 0 | 1.82 |
| 2025-04 | 0 | 1.79 |
| 2025-05 | 0 | 1.88 |
| 2025-06 | 0 | 1.83 |
| 2025-07 | 0 | 1.65 |
| 2025-08 | 0 | 1.64 |
| 2025-09 | 0 | 1.46 |
| 2025-10 | 0 | 1.6 |
| 2025-11 | 0 | 1.71 |
| 2025-12 | 0 | 2.09 |
| 2026-01 | 0 | 1.84 |
| 2026-02 | 0 | 1.72 |
| 2026-03 | 0 | 1.73 |
| 2026-04 | 0 | 1.71 |
| 2026-05 | 0 | 1.7 |
| 2026-06 | 0 | 1.64 |
Regulatory clearances
- K143256 SESE 2015-05-28 (k number procode)
Predicate lineage
K143256 — cites (transitively): K030710 (d1), K113254 (d1), K133349 (d1) — cited as predicate by K153602, K170893, K172054, K190286, K193560, K212569, K220452, K221758, K230315, K231112, K233408, K241143, K242813, K243955, K251558, K260802
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — LIMACORPORATE SPA
Nothing in the loaded window.