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ACE-FISCHER ™LARGE FOOT FRAME
Model 8180-04-012 · Biomet Orthopedics, LLC · DI 00887868047565
HXK — Holder, Needle; Orthopedic · Class I · 21 CFR 888.4540
JDW — Pin, Fixation, Threaded · Class II · 21 CFR 888.3040
KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-15 · 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
1.59
2019-02
0
1.58
2019-03
0
1.32
2019-04
0
2
2019-05
0
1.48
2019-06
0
1.57
2019-07
0
2
2019-08
0
4.5
2019-09
0
1.4
2019-10
0
1.22
2019-11
0
1.52
2019-12
0
1.64
2020-01
0
2.27
2020-02
0
2.34
2020-03
0
1.5
2020-04
0
1.5
2020-05
0
1.4
2020-06
0
2
2020-07
0
1.48
2020-08
0
2
2020-09
0
2.38
2020-10
0
2.2
2020-11
0
1.95
2020-12
0
2.21
2021-01
0
1.61
2021-02
0
2.84
2021-03
0
3.06
2021-04
0
2.44
2021-05
0
4.26
2021-06
0
2.07
2021-07
0
1.74
2021-08
0
1.66
2021-09
0
1.68
2021-10
0
1.64
2021-11
0
2.94
2021-12
0
1.61
2022-01
0
2
2022-02
0
2.71
2022-03
0
2.13
2022-04
0
2.39
2022-05
0
3.69
2022-06
0
2.35
2022-07
0
2.13
2022-08
0
2
2022-09
0
2.43
2022-10
0
2.86
2022-11
0
3.31
2022-12
0
2.36
2023-01
0
2.59
2023-02
0
2.1
2023-03
0
1.96
2023-04
0
2.22
2023-05
0
2.93
2023-06
0
2.13
2023-07
0
2
2023-08
0
1.45
2023-09
0
2.1
2023-10
0
1.18
2023-11
0
1.5
2023-12
0
1.33
2024-01
0
1.18
2024-02
0
2
2024-03
0
1.35
2024-04
0
1.89
2024-05
0
1.44
2024-06
0
1.53
2024-07
0
1.08
2024-08
0
1.63
2024-09
0
1.24
2024-10
0
1.82
2024-11
0
1.65
2024-12
0
3.8
2025-01
0
1.55
2025-02
0
2
2025-03
0
1.25
2025-04
0
2
2025-05
0
1.4
2025-06
0
1.31
2025-07
0
1.71
2025-08
0
1.22
2025-09
0
1.47
2025-10
0
2.45
2025-11
0
1.78
2025-12
0
1.64
2026-01
0
1.5
2026-02
0
1.55
2026-03
0
1.29
2026-04
0
1.25
2026-05
0
3
2026-06
0
1.36
This device (reports/month)Average device in HXK, JDW, KTT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K083789 — cited as predicate by K093753, K111993, K190486
K112218 — cited as predicate by K181630
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC