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1/3 COMPOSITE RING, MEDIUM

Model FC-10030 · Biomet Orthopedics, LLC · DI 00887868071065

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

LXT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite · 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	1.56
2019-02	0	1.65
2019-03	0	1.29
2019-04	0	1.96
2019-05	0	1.46
2019-06	0	1.72
2019-07	0	1.93
2019-08	0	4.33
2019-09	0	1.37
2019-10	0	1.23
2019-11	0	1.48
2019-12	0	1.64
2020-01	0	2.23
2020-02	0	2.26
2020-03	0	1.5
2020-04	0	1.5
2020-05	0	1.23
2020-06	0	2
2020-07	0	1.52
2020-08	0	1.91
2020-09	0	2.18
2020-10	0	2.19
2020-11	0	1.91
2020-12	0	2.25
2021-01	0	1.53
2021-02	0	2.84
2021-03	0	3.11
2021-04	0	2.37
2021-05	0	4.06
2021-06	0	2.02
2021-07	0	1.67
2021-08	0	1.66
2021-09	0	1.67
2021-10	0	1.54
2021-11	0	2.8
2021-12	0	1.6
2022-01	0	2
2022-02	0	2.61
2022-03	0	1.96
2022-04	0	2.29
2022-05	0	3.83
2022-06	0	2.26
2022-07	0	2.28
2022-08	0	1.86
2022-09	0	2.35
2022-10	0	2.68
2022-11	0	3.29
2022-12	0	2.67
2023-01	0	2.48
2023-02	0	2.09
2023-03	0	1.93
2023-04	0	2.22
2023-05	0	2.96
2023-06	0	1.89
2023-07	0	1.95
2023-08	0	1.42
2023-09	0	2
2023-10	0	1.17
2023-11	0	1.47
2023-12	0	1.31
2024-01	0	1.18
2024-02	0	1.88
2024-03	0	1.35
2024-04	0	1.69
2024-05	0	1.43
2024-06	0	1.65
2024-07	0	1.24
2024-08	0	1.57
2024-09	0	1.26
2024-10	0	2.08
2024-11	0	1.61
2024-12	0	3.33
2025-01	0	1.55
2025-02	0	1.95
2025-03	0	1.25
2025-04	0	2
2025-05	0	1.44
2025-06	0	1.25
2025-07	0	1.73
2025-08	0	1.19
2025-09	0	1.41
2025-10	0	2.46
2025-11	0	1.67
2025-12	0	1.58
2026-01	0	1.47
2026-02	0	1.27
2026-03	0	1.25
2026-04	0	1.4
2026-05	0	2.69
2026-06	0	1.33

This device (reports/month)Average device in JDW, KTT, LXT (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

Nothing in the loaded window.