HEALIX TI PERMACORD
Model 223144 · Medos International Sàrl · DI 10886705024841
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
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 (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 | 4.67 |
| 2019-02 | 0 | 2.34 |
| 2019-03 | 0 | 3.13 |
| 2019-04 | 0 | 3.17 |
| 2019-05 | 0 | 3.26 |
| 2019-06 | 0 | 2.82 |
| 2019-07 | 0 | 3.81 |
| 2019-08 | 0 | 3.49 |
| 2019-09 | 0 | 3.35 |
| 2019-10 | 0 | 3.19 |
| 2019-11 | 0 | 5.28 |
| 2019-12 | 0 | 5.45 |
| 2020-01 | 0 | 5.46 |
| 2020-02 | 0 | 4.5 |
| 2020-03 | 0 | 3.98 |
| 2020-04 | 0 | 5.42 |
| 2020-05 | 0 | 3.88 |
| 2020-06 | 0 | 3.71 |
| 2020-07 | 0 | 3.74 |
| 2020-08 | 0 | 4.23 |
| 2020-09 | 0 | 4.05 |
| 2020-10 | 0 | 4.53 |
| 2020-11 | 0 | 6.39 |
| 2020-12 | 0 | 5.41 |
| 2021-01 | 0 | 4.74 |
| 2021-02 | 0 | 3.95 |
| 2021-03 | 0 | 3.83 |
| 2021-04 | 0 | 3.82 |
| 2021-05 | 0 | 4.06 |
| 2021-06 | 0 | 4.11 |
| 2021-07 | 0 | 4 |
| 2021-08 | 0 | 4.46 |
| 2021-09 | 0 | 4.05 |
| 2021-10 | 0 | 4.44 |
| 2021-11 | 0 | 4.37 |
| 2021-12 | 0 | 4.43 |
| 2022-01 | 0 | 4 |
| 2022-02 | 0 | 3.37 |
| 2022-03 | 0 | 3.88 |
| 2022-04 | 0 | 3.8 |
| 2022-05 | 0 | 4.06 |
| 2022-06 | 0 | 3.85 |
| 2022-07 | 0 | 3.56 |
| 2022-08 | 0 | 4.39 |
| 2022-09 | 0 | 3.86 |
| 2022-10 | 0 | 4.15 |
| 2022-11 | 0 | 2.87 |
| 2022-12 | 0 | 3.93 |
| 2023-01 | 0 | 3.27 |
| 2023-02 | 0 | 3.2 |
| 2023-03 | 0 | 3.8 |
| 2023-04 | 0 | 4.26 |
| 2023-05 | 0 | 4.67 |
| 2023-06 | 0 | 4.2 |
| 2023-07 | 0 | 3.85 |
| 2023-08 | 0 | 4.49 |
| 2023-09 | 0 | 4.47 |
| 2023-10 | 0 | 4.71 |
| 2023-11 | 0 | 4.63 |
| 2023-12 | 0 | 5.49 |
| 2024-01 | 0 | 5.56 |
| 2024-02 | 0 | 4.93 |
| 2024-03 | 0 | 4.78 |
| 2024-04 | 0 | 5.43 |
| 2024-05 | 0 | 6.48 |
| 2024-06 | 0 | 7.52 |
| 2024-07 | 0 | 4.11 |
| 2024-08 | 0 | 4.21 |
| 2024-09 | 0 | 5 |
| 2024-10 | 0 | 4.7 |
| 2024-11 | 0 | 4.41 |
| 2024-12 | 0 | 4.25 |
| 2025-01 | 0 | 5.12 |
| 2025-02 | 0 | 4.81 |
| 2025-03 | 0 | 4.57 |
| 2025-04 | 0 | 4.98 |
| 2025-05 | 0 | 5.81 |
| 2025-06 | 0 | 5.47 |
| 2025-07 | 0 | 5.19 |
| 2025-08 | 0 | 5.08 |
| 2025-09 | 0 | 4.29 |
| 2025-10 | 0 | 4.62 |
| 2025-11 | 0 | 5.25 |
| 2025-12 | 0 | 6.07 |
| 2026-01 | 0 | 5.06 |
| 2026-02 | 0 | 5.39 |
| 2026-03 | 0 | 5.98 |
| 2026-04 | 0 | 5.93 |
| 2026-05 | 0 | 5.88 |
| 2026-06 | 0 | 6.16 |
Regulatory clearances
- K142574 SESE 2014-10-24 (k number procode)
Predicate lineage
K142574 — cites (transitively): K082282 (d1), K133794 (d1), K140324 (d1), K070673 (d2), K073412 (d2), K092533 (d2), K100012 (d2), K120449 (d2), K083070 (d2), K123362 (d2), K130033 (d2), K071481 (d3), K090124 (d3), K032717 (d3), K060830 (d3), K102982 (d3), K980155 (d4)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Medos International Sàrl
Nothing in the loaded window.