Easytech Anatomical Shoulder System
Model 314-0038 · FX SOLUTIONS · DI 03701037301487
PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained · Class II · 21 CFR 888.3660
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 (18)
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: 18
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-03 | 0 | 1 |
| 2019-05 | 0 | 1 |
| 2019-08 | 0 | 1.67 |
| 2019-10 | 0 | 1.17 |
| 2019-11 | 0 | 1.67 |
| 2019-12 | 0 | 1 |
| 2020-01 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-08 | 0 | 1 |
| 2020-09 | 0 | 1 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 1 |
| 2021-06 | 0 | 1 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-10 | 3 | 2.2 |
| 2021-11 | 0 | 2.5 |
| 2021-12 | 5 | 7 |
| 2022-01 | 1 | 2.25 |
| 2022-02 | 0 | 1.75 |
| 2022-03 | 1 | 2 |
| 2022-04 | 0 | 3 |
| 2022-05 | 0 | 1 |
| 2022-06 | 0 | 1.33 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 1 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1.5 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 1 |
| 2023-03 | 1 | 1 |
| 2023-04 | 0 | 2 |
| 2023-05 | 1 | 1.5 |
| 2023-06 | 0 | 1.4 |
| 2023-07 | 0 | 1.8 |
| 2023-08 | 0 | 1.25 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 1.67 |
| 2023-11 | 0 | 1.33 |
| 2023-12 | 1 | 2 |
| 2024-01 | 0 | 1 |
| 2024-02 | 1 | 1 |
| 2024-03 | 0 | 1.14 |
| 2024-04 | 0 | 2 |
| 2024-06 | 0 | 1.25 |
| 2024-07 | 0 | 1 |
| 2024-08 | 0 | 1.67 |
| 2024-09 | 0 | 1.5 |
| 2024-10 | 0 | 1 |
| 2024-11 | 0 | 1 |
| 2024-12 | 0 | 1.25 |
| 2025-01 | 0 | 2.17 |
| 2025-02 | 0 | 2 |
| 2025-03 | 0 | 1.33 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 1 |
| 2025-06 | 2 | 1.75 |
| 2025-07 | 0 | 1.25 |
| 2025-08 | 0 | 1.5 |
| 2025-10 | 0 | 1.17 |
| 2025-11 | 0 | 1.67 |
| 2025-12 | 0 | 2 |
| 2026-01 | 0 | 3 |
| 2026-02 | 0 | 1.44 |
| 2026-03 | 0 | 2 |
| 2026-04 | 0 | 1.5 |
| 2026-05 | 1 | 1.33 |
| 2026-06 | 1 | 1.2 |
Regulatory clearances
- K201391 SESE 2021-02-16 (k number procode)
Predicate lineage
K201391 — cites (transitively): K111097 (d1), K123814 (d1), K130759 (d1), K143552 (d1), K162455 (d1), K163669 (d1), K183194 (d1), K060874 (d2), K992525 (d2), K103007 (d2), K030941 (d2), K082120 (d2), K100142 (d2), K150488 (d2), K122698 (d2), K071032 (d2), K171858 (d2), K173388 (d2), K060988 (d3), K073331 (d3), K053274 (d3), K132285 (d3), K140071 (d3), K982981 (d3), K042021 (d3), K102975 (d3), K131298 (d3), K140063 (d3), K153595 (d3), K070479 (d4), K023096 (d4), K093430 (d4), K994392 (d4), K143393 (d4), K053340 (d5), K100391 (d5), K123486 (d5), K132624 (d5), K042871 (d6), K052888 (d6), K072160 (d6), K031729 (d6), K040267 (d6), K042883 (d6), K042993 (d6), K051146 (d6), K051380 (d6), K051977 (d6), K053514 (d6), K061521 (d6), K072221 (d6), K072575 (d6), K123166 (d6), K050539 (d7), K063423 (d7), K974556 (d7) — cited as predicate by K254154
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — FX SOLUTIONS
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