HEALIX ADVANCE PERMACORD
Model 223129 · Medos International Sàrl · DI 10886705024735
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
MAI — Fastener, Fixation, Biodegradable, Soft Tissue · Class II · 21 CFR 888.3030
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 (48)
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.
Malfunction: 41 · Injury: 7
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 3.04 |
| 2019-02 | 0 | 1.81 |
| 2019-03 | 0 | 1.76 |
| 2019-04 | 0 | 2.23 |
| 2019-05 | 0 | 1.9 |
| 2019-06 | 1 | 1.98 |
| 2019-07 | 2 | 2.08 |
| 2019-08 | 0 | 2.12 |
| 2019-09 | 3 | 2.14 |
| 2019-10 | 1 | 1.93 |
| 2019-11 | 1 | 2.23 |
| 2019-12 | 1 | 2.7 |
| 2020-01 | 1 | 2.62 |
| 2020-02 | 2 | 2.1 |
| 2020-03 | 1 | 2.1 |
| 2020-04 | 0 | 2.18 |
| 2020-05 | 0 | 1.94 |
| 2020-06 | 0 | 2.23 |
| 2020-07 | 0 | 2.71 |
| 2020-08 | 0 | 2.7 |
| 2020-09 | 0 | 2.55 |
| 2020-10 | 0 | 2.59 |
| 2020-11 | 0 | 3.23 |
| 2020-12 | 0 | 3.06 |
| 2021-01 | 0 | 2.2 |
| 2021-02 | 0 | 2.5 |
| 2021-03 | 0 | 2.84 |
| 2021-04 | 1 | 3.1 |
| 2021-05 | 0 | 2.78 |
| 2021-06 | 1 | 2.42 |
| 2021-07 | 2 | 2.47 |
| 2021-08 | 0 | 2.4 |
| 2021-09 | 0 | 2.83 |
| 2021-10 | 0 | 2.65 |
| 2021-11 | 0 | 2.75 |
| 2021-12 | 1 | 2.8 |
| 2022-01 | 1 | 3.48 |
| 2022-02 | 0 | 2.55 |
| 2022-03 | 1 | 2.47 |
| 2022-04 | 0 | 2.4 |
| 2022-05 | 1 | 2.63 |
| 2022-06 | 2 | 2.41 |
| 2022-07 | 0 | 2.53 |
| 2022-08 | 0 | 2.7 |
| 2022-09 | 1 | 2.98 |
| 2022-10 | 1 | 3.17 |
| 2022-11 | 3 | 2.87 |
| 2022-12 | 1 | 4.86 |
| 2023-01 | 1 | 2.9 |
| 2023-02 | 1 | 2.88 |
| 2023-03 | 1 | 3.19 |
| 2023-04 | 3 | 3.04 |
| 2023-05 | 0 | 3.42 |
| 2023-06 | 1 | 3.26 |
| 2023-07 | 1 | 2.61 |
| 2023-08 | 0 | 2.62 |
| 2023-09 | 0 | 2.53 |
| 2023-10 | 0 | 2.62 |
| 2023-11 | 0 | 2.48 |
| 2023-12 | 1 | 2.95 |
| 2024-01 | 0 | 3.27 |
| 2024-02 | 0 | 2.22 |
| 2024-03 | 0 | 2.87 |
| 2024-04 | 1 | 2.71 |
| 2024-05 | 0 | 2.74 |
| 2024-06 | 1 | 2.87 |
| 2024-07 | 0 | 2.89 |
| 2024-08 | 1 | 2.43 |
| 2024-09 | 0 | 2.74 |
| 2024-10 | 0 | 2.7 |
| 2024-11 | 0 | 2.66 |
| 2024-12 | 0 | 3.28 |
| 2025-01 | 0 | 3.1 |
| 2025-02 | 2 | 2.72 |
| 2025-03 | 0 | 2.7 |
| 2025-04 | 1 | 2.98 |
| 2025-05 | 0 | 3.07 |
| 2025-06 | 0 | 2.86 |
| 2025-07 | 0 | 2.9 |
| 2025-08 | 0 | 3.03 |
| 2025-09 | 0 | 2.85 |
| 2025-10 | 0 | 3.15 |
| 2025-11 | 0 | 2.95 |
| 2025-12 | 2 | 3.81 |
| 2026-01 | 1 | 3.22 |
| 2026-02 | 0 | 3.44 |
| 2026-03 | 0 | 3.4 |
| 2026-04 | 0 | 3.22 |
| 2026-05 | 0 | 3.77 |
| 2026-06 | 0 | 3.49 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K073412 — cited as predicate by K100012, K102298, K103712, K112249, K133794, K170639, K171299, K183501, K243790
K100012 — cites (transitively): K071481 (d1), K073412 (d1), K090124 (d1) — cited as predicate by K103712, K120078, K133794, K140643, K141259, K170639
K133794 — cites (transitively): K070673 (d1), K073412 (d1), K092533 (d1), K100012 (d1), K120449 (d1), K071481 (d2), K090124 (d2) — cited as predicate by K142574, K170639, K173859, K183506
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Medos International Sàrl
Nothing in the loaded window.