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PYXIS 3D Titanium Cage System
Model GS166-0105 · GS Medical Co., Ltd. · DI 08809885719845
LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540
MAX — Intervertebral Fusion Device With Bone Graft, Lumbar · Class II · 21 CFR 888.3080
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 (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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2.3
2019-02
0
2.13
2019-03
0
2.12
2019-04
0
1.95
2019-05
0
2.09
2019-06
0
2.14
2019-07
0
2.19
2019-08
0
2.06
2019-09
0
2.46
2019-10
0
2.07
2019-11
0
2.01
2019-12
0
2.14
2020-01
0
2.23
2020-02
0
2.01
2020-03
0
2.03
2020-04
0
2.16
2020-05
0
1.99
2020-06
0
2.49
2020-07
0
3.34
2020-08
0
3.13
2020-09
0
3.35
2020-10
0
3.68
2020-11
0
3.42
2020-12
0
3.39
2021-01
0
3.46
2021-02
0
3.42
2021-03
0
3.04
2021-04
0
3.2
2021-05
0
3.04
2021-06
0
2.92
2021-07
0
2.56
2021-08
0
3.08
2021-09
0
2.63
2021-10
0
2.48
2021-11
0
2.89
2021-12
0
2.65
2022-01
0
2.68
2022-02
0
3.07
2022-03
0
2.87
2022-04
0
3.21
2022-05
0
3.41
2022-06
0
2.69
2022-07
0
2.46
2022-08
0
2.47
2022-09
0
2.68
2022-10
0
2.93
2022-11
0
3.35
2022-12
0
3.38
2023-01
0
4.28
2023-02
0
2.91
2023-03
0
3.32
2023-04
0
2.85
2023-05
0
3.05
2023-06
0
2.99
2023-07
0
2.75
2023-08
0
2.7
2023-09
0
2.18
2023-10
0
2.33
2023-11
0
4.26
2023-12
0
3.2
2024-01
0
2.64
2024-02
0
2.89
2024-03
0
2.65
2024-04
0
3.34
2024-05
0
3.45
2024-06
0
3.54
2024-07
0
2.71
2024-08
0
2.67
2024-09
0
2.87
2024-10
0
2.93
2024-11
0
2.63
2024-12
0
2.39
2025-01
0
2.63
2025-02
0
3.78
2025-03
0
4.16
2025-04
0
2.57
2025-05
0
2.67
2025-06
0
2.64
2025-07
0
2.45
2025-08
0
2.48
2025-09
0
2.03
2025-10
0
2.23
2025-11
0
2.57
2025-12
0
3.51
2026-01
0
3.26
2026-02
0
3.08
2026-03
0
3.12
2026-04
0
2.86
2026-05
0
2.42
2026-06
0
3.03
This device (reports/month)Average device in LXH, MAX (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K100516 — cited as predicate by K110783, K121567, K221687, K221719, K221844, K223868
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — GS Medical Co., Ltd.