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ALLTHREAD LACTOSORB
Model 905944 · Biomet Orthopedics, LLC · DI 00880304445130
HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030
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
3.08
2019-02
0
1.8
2019-03
0
2.02
2019-04
0
2.44
2019-05
0
2.08
2019-06
0
2.03
2019-07
0
2.25
2019-08
0
2.22
2019-09
0
2.31
2019-10
0
2.11
2019-11
0
2.81
2019-12
0
2.92
2020-01
0
2.97
2020-02
0
1.66
2020-03
0
2.41
2020-04
0
2.83
2020-05
0
2.23
2020-06
0
2.47
2020-07
0
2.65
2020-08
0
2.85
2020-09
0
2.84
2020-10
0
2.75
2020-11
0
3.65
2020-12
0
3.38
2021-01
0
2.43
2021-02
0
2.74
2021-03
0
2.85
2021-04
0
3.14
2021-05
0
3.05
2021-06
0
2.7
2021-07
0
2.73
2021-08
0
2.63
2021-09
0
2.88
2021-10
0
2.95
2021-11
0
2.96
2021-12
0
3.08
2022-01
0
3.49
2022-02
0
2.65
2022-03
0
2.72
2022-04
0
2.54
2022-05
0
2.71
2022-06
0
2.71
2022-07
0
2.69
2022-08
0
2.94
2022-09
0
3.05
2022-10
0
3.4
2022-11
0
2.86
2022-12
0
4.1
2023-01
0
3.01
2023-02
0
2.87
2023-03
0
3.32
2023-04
0
3.29
2023-05
0
3.84
2023-06
0
3.51
2023-07
0
2.82
2023-08
0
2.96
2023-09
0
3.09
2023-10
0
3.08
2023-11
0
3
2023-12
0
3.68
2024-01
0
3.72
2024-02
0
2.89
2024-03
0
3.24
2024-04
0
3.25
2024-05
0
3.75
2024-06
0
4.17
2024-07
0
3.08
2024-08
0
2.9
2024-09
0
3.09
2024-10
0
3.27
2024-11
0
3.04
2024-12
0
3.51
2025-01
0
3.48
2025-02
0
3.21
2025-03
0
3.24
2025-04
0
3.37
2025-05
0
3.63
2025-06
0
3.38
2025-07
0
3.37
2025-08
0
3.38
2025-09
0
3.24
2025-10
0
3.44
2025-11
0
3.37
2025-12
0
4.3
2026-01
0
3.65
2026-02
0
3.81
2026-03
0
4.08
2026-04
0
3.88
2026-05
0
4.43
2026-06
0
4.05
This device (reports/month)Average device in HRS, 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