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ACL CROSSPIN
Model 905855 · Biomet Sports Medicine, LLC · DI 00880304421301
HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030
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
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
3.39
2019-02
0
1.73
2019-03
0
1.95
2019-04
0
2.33
2019-05
0
1.94
2019-06
0
1.88
2019-07
0
1.9
2019-08
0
1.88
2019-09
0
2.45
2019-10
0
2.03
2019-11
0
2.34
2019-12
0
2.35
2020-01
0
2.36
2020-02
0
1.36
2020-03
0
2.08
2020-04
0
2.66
2020-05
0
2.04
2020-06
0
2.36
2020-07
0
2.21
2020-08
0
2.6
2020-09
0
2.7
2020-10
0
2.43
2020-11
0
3.25
2020-12
0
3.1
2021-01
0
2.26
2021-02
0
2.39
2021-03
0
2.57
2021-04
0
3.05
2021-05
0
2.95
2021-06
0
2.5
2021-07
0
2.42
2021-08
0
2.25
2021-09
0
2.76
2021-10
0
2.67
2021-11
0
2.9
2021-12
0
2.75
2022-01
0
3.6
2022-02
0
2.63
2022-03
0
2.7
2022-04
0
2.66
2022-05
0
2.46
2022-06
0
2.63
2022-07
0
2.71
2022-08
0
2.8
2022-09
0
2.87
2022-10
0
3.48
2022-11
0
2.68
2022-12
0
3.1
2023-01
0
3.29
2023-02
0
2.72
2023-03
0
3.19
2023-04
0
3.37
2023-05
0
3.79
2023-06
0
3.58
2023-07
0
2.67
2023-08
0
2.88
2023-09
0
3.01
2023-10
0
2.91
2023-11
0
3.06
2023-12
0
3.26
2024-01
0
3.24
2024-02
0
2.56
2024-03
0
2.91
2024-04
0
2.98
2024-05
0
2.78
2024-06
0
3.25
2024-07
0
2.94
2024-08
0
2.87
2024-09
0
2.77
2024-10
0
3.13
2024-11
0
3.09
2024-12
0
3.57
2025-01
0
3.58
2025-02
0
2.87
2025-03
0
3.16
2025-04
0
2.96
2025-05
0
3.21
2025-06
0
2.94
2025-07
0
3.23
2025-08
0
3.18
2025-09
0
3.26
2025-10
0
3.22
2025-11
0
3.23
2025-12
0
4.08
2026-01
0
3.85
2026-02
0
3.7
2026-03
0
4.01
2026-04
0
3.94
2026-05
0
4.98
2026-06
0
4.21
This device (reports/month)Average device in HRS, HTY, JDR, MAI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Biomet Sports Medicine, LLC