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IM NAIL PLATFORMCANCELLOUS SCREW
Model 1819-48-040 · Biomet Orthopedics, LLC · DI 00887868022371
HSB — Rod, Fixation, Intramedullary And Accessories · Class II · 21 CFR 888.3020
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
UDILibrary device dossier · generated 2026-09-13 · 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
1.96
2019-02
0
1.54
2019-03
0
1.64
2019-04
0
1.9
2019-05
0
1.6
2019-06
0
1.72
2019-07
0
1.88
2019-08
0
1.94
2019-09
0
1.62
2019-10
0
1.6
2019-11
0
1.85
2019-12
0
2.14
2020-01
0
2.28
2020-02
0
1.91
2020-03
0
1.73
2020-04
0
1.91
2020-05
0
1.78
2020-06
0
2.1
2020-07
0
2.5
2020-08
0
2.73
2020-09
0
2.31
2020-10
0
2.33
2020-11
0
3.01
2020-12
0
2.9
2021-01
0
2.3
2021-02
0
2.63
2021-03
0
2.88
2021-04
0
3.05
2021-05
0
3.26
2021-06
0
2.62
2021-07
0
2.37
2021-08
0
2.06
2021-09
0
2.31
2021-10
0
1.92
2021-11
0
2.73
2021-12
0
2.35
2022-01
0
2.93
2022-02
0
2.13
2022-03
0
2.13
2022-04
0
2.1
2022-05
0
2.25
2022-06
0
2.21
2022-07
0
2.01
2022-08
0
2.27
2022-09
0
2.65
2022-10
0
2.78
2022-11
0
2.78
2022-12
0
4.05
2023-01
0
2.5
2023-02
0
2.6
2023-03
0
2.9
2023-04
0
2.6
2023-05
0
3.05
2023-06
0
2.78
2023-07
0
2.14
2023-08
0
1.99
2023-09
0
1.8
2023-10
0
1.85
2023-11
0
1.75
2023-12
0
2.14
2024-01
0
2.35
2024-02
0
1.7
2024-03
0
2.08
2024-04
0
1.88
2024-05
0
2.13
2024-06
0
2.07
2024-07
0
1.99
2024-08
0
2.04
2024-09
0
2.17
2024-10
0
1.98
2024-11
0
1.89
2024-12
0
2.26
2025-01
0
2.01
2025-02
0
1.93
2025-03
0
1.87
2025-04
0
2.18
2025-05
0
2.09
2025-06
0
1.75
2025-07
0
1.93
2025-08
0
2.11
2025-09
0
1.84
2025-10
0
2.01
2025-11
0
1.9
2025-12
0
2.3
2026-01
0
1.98
2026-02
0
2
2026-03
0
2.3
2026-04
0
1.96
2026-05
0
2.24
2026-06
0
2.07
This device (reports/month)Average device in HSB, HWC (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K033806 — cited as predicate by K111663, K181827
K033878 — cited as predicate by K111663, K172189, K181827
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC