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HEALIX ADVANCE ORTHOCORD
Model 222295 · Medos International Sàrl · DI 10886705021314
MAI — Fastener, Fixation, Biodegradable, Soft Tissue · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-13 · 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 (563)
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: 552 · Injury: 11
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
4
4.94
2019-02
1
2.37
2019-03
0
2.38
2019-04
1
2.23
2019-05
2
2.36
2019-06
0
2.52
2019-07
0
2.15
2019-08
0
2.48
2019-09
1
3.14
2019-10
0
2.89
2019-11
0
2.69
2019-12
1
3.19
2020-01
0
2.86
2020-02
0
1.96
2020-03
1
2.63
2020-04
0
3.29
2020-05
0
2.58
2020-06
0
2.93
2020-07
3
2.81
2020-08
0
3.33
2020-09
2
2.85
2020-10
6
3.51
2020-11
0
4.62
2020-12
2
4.26
2021-01
2
3.6
2021-02
1
2.98
2021-03
1
3.43
2021-04
0
4.38
2021-05
2
3.6
2021-06
0
2.9
2021-07
0
2.84
2021-08
0
3.22
2021-09
4
3.7
2021-10
1
3.56
2021-11
0
3.73
2021-12
0
3.46
2022-01
5
4.24
2022-02
2
3.21
2022-03
3
3.4
2022-04
1
3.56
2022-05
1
3.12
2022-06
2
2.83
2022-07
0
3.42
2022-08
2
3.29
2022-09
0
3.25
2022-10
1
3.53
2022-11
2
2.59
2022-12
1
3.6
2023-01
0
3.25
2023-02
1
2.96
2023-03
4
3.39
2023-04
3
3.84
2023-05
9
3.67
2023-06
4
3.84
2023-07
4
3.17
2023-08
7
3.37
2023-09
7
3.48
2023-10
5
3.26
2023-11
8
3.55
2023-12
7
3.85
2024-01
8
4.1
2024-02
6
3.07
2024-03
8
3.59
2024-04
9
3.65
2024-05
5
3.3
2024-06
8
3.64
2024-07
6
3.45
2024-08
5
2.96
2024-09
8
3.83
2024-10
9
3.42
2024-11
16
3.69
2024-12
11
4.03
2025-01
8
4.28
2025-02
13
3.4
2025-03
11
3.74
2025-04
15
3.6
2025-05
23
3.92
2025-06
18
4.07
2025-07
21
4.17
2025-08
16
4.18
2025-09
12
3.88
2025-10
18
3.92
2025-11
15
4.25
2025-12
27
5.38
2026-01
21
4.74
2026-02
22
4.72
2026-03
16
4.76
2026-04
23
4.8
2026-05
41
5.95
2026-06
30
5.43
This device (reports/month)Average device in MAI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K120078 — cites (transitively): K100012 (d1), K071481 (d2), K073412 (d2), K090124 (d2) — cited as predicate by K173859
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Medos International Sàrl