Print-ready dossier — use your browser's print dialog to save as PDF.
ALLTHREAD LACTOSORB
Model 905945 · Biomet Orthopedics, LLC · DI 00880304481206
HWC — Screw, Fixation, Bone · 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
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
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
3.43
2019-02
0
1.91
2019-03
0
2.08
2019-04
0
2.48
2019-05
0
2.23
2019-06
0
2.18
2019-07
0
2.47
2019-08
0
2.42
2019-09
0
2.49
2019-10
0
2.32
2019-11
0
3.1
2019-12
0
3.36
2020-01
0
3.26
2020-02
0
2.64
2020-03
0
2.68
2020-04
0
3.13
2020-05
0
2.39
2020-06
0
2.66
2020-07
0
2.92
2020-08
0
3.11
2020-09
0
2.88
2020-10
0
3.09
2020-11
0
4.03
2020-12
0
3.7
2021-01
0
2.74
2021-02
0
2.98
2021-03
0
3.1
2021-04
0
3.22
2021-05
0
3.18
2021-06
0
2.89
2021-07
0
2.87
2021-08
0
2.9
2021-09
0
3.18
2021-10
0
3.19
2021-11
0
3.18
2021-12
0
3.31
2022-01
0
3.61
2022-02
0
2.79
2022-03
0
2.94
2022-04
0
2.7
2022-05
0
2.94
2022-06
0
2.79
2022-07
0
2.79
2022-08
0
3.2
2022-09
0
3.23
2022-10
0
3.52
2022-11
0
2.84
2022-12
0
4.38
2023-01
0
3.12
2023-02
0
2.94
2023-03
0
3.39
2023-04
0
3.35
2023-05
0
3.76
2023-06
0
3.66
2023-07
0
2.96
2023-08
0
3.14
2023-09
0
3.27
2023-10
0
3.21
2023-11
0
3.18
2023-12
0
3.89
2024-01
0
4.04
2024-02
0
3.06
2024-03
0
3.52
2024-04
0
3.48
2024-05
0
4.09
2024-06
0
4.51
2024-07
0
3.25
2024-08
0
3.02
2024-09
0
3.48
2024-10
0
3.42
2024-11
0
3.29
2024-12
0
3.64
2025-01
0
3.82
2025-02
0
3.42
2025-03
0
3.38
2025-04
0
3.66
2025-05
0
3.92
2025-06
0
3.78
2025-07
0
3.68
2025-08
0
3.73
2025-09
0
3.47
2025-10
0
3.77
2025-11
0
3.8
2025-12
0
4.65
2026-01
0
3.99
2026-02
0
4.25
2026-03
0
4.29
2026-04
0
4.1
2026-05
0
4.79
2026-06
0
4.46
This device (reports/month)Average device in HWC, JDR, MAI, MBI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K080088 — cited as predicate by K110473, K123485, K192942, K193402
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC