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GRYPHON ORTHOCORD
Model 210813 · Medos International Sàrl · DI 10886705001279
HTY — Pin, Fixation, Smooth · Class II · 21 CFR 888.3040
JDR — Staple, Fixation, Bone · Class II · 21 CFR 888.3030
MAI — Fastener, Fixation, Biodegradable, Soft Tissue · Class II · 21 CFR 888.3030
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
UDILibrary device dossier · generated 2026-09-08 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (2)
Initiated
Recall #
Class
Status
Reason
Link basis
2011-02-24
Z-2210-2011
Terminated
Metal debris in the shaft component of the device
k number procode
2011-02-24
Z-2211-2011
Terminated
Metal debris in the shaft component of the device
k number procode
Adverse-event reports — MAUDE (594)
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: 560 · Injury: 34
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
12
4.44
2019-02
2
2.09
2019-03
3
2.56
2019-04
0
2.69
2019-05
3
2.62
2019-06
3
2.46
2019-07
0
2.82
2019-08
1
2.73
2019-09
6
3.2
2019-10
0
2.97
2019-11
9
3.71
2019-12
4
3.86
2020-01
3
3.82
2020-02
3
3.09
2020-03
0
3.18
2020-04
3
4.32
2020-05
0
2.94
2020-06
2
3.34
2020-07
2
3.05
2020-08
7
3.56
2020-09
0
3.23
2020-10
2
3.62
2020-11
3
5.02
2020-12
10
4.4
2021-01
6
3.79
2021-02
2
3.37
2021-03
2
3.4
2021-04
3
3.54
2021-05
6
3.65
2021-06
6
3.41
2021-07
1
3.2
2021-08
1
3.45
2021-09
1
3.67
2021-10
1
3.76
2021-11
4
3.84
2021-12
4
3.67
2022-01
8
3.95
2022-02
0
3.17
2022-03
10
3.55
2022-04
0
3.5
2022-05
3
3.33
2022-06
4
3.24
2022-07
0
3.26
2022-08
1
3.88
2022-09
4
3.47
2022-10
4
3.99
2022-11
3
2.66
2022-12
0
3.57
2023-01
5
3.54
2023-02
0
3.01
2023-03
3
3.55
2023-04
7
3.89
2023-05
11
4.04
2023-06
6
4.12
2023-07
9
3.34
2023-08
17
3.79
2023-09
5
3.96
2023-10
10
3.8
2023-11
24
4.06
2023-12
3
4.62
2024-01
7
4.71
2024-02
7
3.95
2024-03
8
4.06
2024-04
8
4.3
2024-05
3
4.78
2024-06
17
5.54
2024-07
4
3.64
2024-08
10
3.63
2024-09
7
4.37
2024-10
7
4.05
2024-11
11
4.06
2024-12
10
4.13
2025-01
13
4.75
2025-02
5
4.03
2025-03
7
4.01
2025-04
5
4.25
2025-05
19
4.64
2025-06
9
4.56
2025-07
18
4.58
2025-08
11
4.57
2025-09
11
4.07
2025-10
13
4.29
2025-11
12
4.76
2025-12
17
5.52
2026-01
18
4.96
2026-02
17
5.12
2026-03
13
5.28
2026-04
21
5.18
2026-05
19
6.09
2026-06
15
5.85
This device (reports/month)Average device in HTY, JDR, MAI, MBI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K090124 — cited as predicate by K100012, K103712, K132241, K140643, K141259, K243790
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Medos International Sàrl