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Arthrex®
Model AR-523-A116 · ARTHREX, INC. · DI 00888867231139
HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3520
KRR — Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3540
MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer · Class II · 21 CFR 888.3565
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.
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
1.36
2019-02
0
1.42
2019-03
0
1.37
2019-04
0
1.5
2019-05
0
1.41
2019-06
0
1.39
2019-07
0
1.48
2019-08
0
1.35
2019-09
0
1.39
2019-10
0
1.35
2019-11
0
1.35
2019-12
0
1.46
2020-01
0
1.36
2020-02
0
1.34
2020-03
0
1.65
2020-04
0
1.26
2020-05
0
1.09
2020-06
0
1.77
2020-07
0
1.78
2020-08
0
1.84
2020-09
0
1.46
2020-10
0
1.35
2020-11
0
1.76
2020-12
0
1.44
2021-01
0
1.45
2021-02
0
1.56
2021-03
0
1.6
2021-04
0
1.56
2021-05
0
1.43
2021-06
0
1.63
2021-07
0
1.54
2021-08
0
1.49
2021-09
0
1.55
2021-10
0
1.53
2021-11
0
1.43
2021-12
0
1.62
2022-01
0
1.32
2022-02
0
1.63
2022-03
0
1.45
2022-04
0
1.46
2022-05
0
1.57
2022-06
0
1.53
2022-07
0
1.45
2022-08
0
1.46
2022-09
0
2.2
2022-10
0
1.45
2022-11
0
1.46
2022-12
0
1.38
2023-01
0
1.43
2023-02
0
1.43
2023-03
0
1.54
2023-04
0
1.51
2023-05
0
1.67
2023-06
0
1.75
2023-07
0
1.4
2023-08
0
1.33
2023-09
0
1.16
2023-10
0
1.25
2023-11
0
1.49
2023-12
0
1.22
2024-01
0
1.31
2024-02
0
1.24
2024-03
0
1.4
2024-04
0
1.36
2024-05
0
1.27
2024-06
0
1.29
2024-07
0
1.22
2024-08
0
1.33
2024-09
0
1.32
2024-10
0
1.4
2024-11
0
1.23
2024-12
0
1.31
2025-01
0
1.35
2025-02
0
1.3
2025-03
0
1.19
2025-04
0
1.3
2025-05
0
1.33
2025-06
0
1.34
2025-07
0
1.39
2025-08
0
1.39
2025-09
0
1.22
2025-10
0
1.32
2025-11
0
1.36
2025-12
0
1.39
2026-01
0
1.35
2026-02
0
1.33
2026-03
0
1.41
2026-04
0
1.3
2026-05
0
1.34
2026-06
0
1.31
This device (reports/month)Average device in HSX, KRR, MBH (reports/device/month)