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ALLthread PEEK-OPTIMA
Model 904900P · Biomet Orthopedics, LLC · DI 00880304644564
FZP — Clip, Implantable · Class II · 21 CFR 878.4300
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
NEU — Marker, Radiographic, Implantable · Class II · 21 CFR 878.4300
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
3.72
2019-02
0
2.56
2019-03
0
3.03
2019-04
0
3.29
2019-05
0
2.72
2019-06
0
2.84
2019-07
0
3.05
2019-08
0
2.9
2019-09
0
2.95
2019-10
0
3.31
2019-11
0
3.57
2019-12
0
4.05
2020-01
0
3.95
2020-02
0
3.36
2020-03
0
3.7
2020-04
0
3.74
2020-05
0
2.67
2020-06
0
3.27
2020-07
0
3.5
2020-08
0
3.58
2020-09
0
3.44
2020-10
0
3.62
2020-11
0
4.61
2020-12
0
4.07
2021-01
0
3.26
2021-02
0
3.53
2021-03
0
3.74
2021-04
0
3.8
2021-05
0
3.42
2021-06
0
3.39
2021-07
0
3.45
2021-08
0
3.82
2021-09
0
3.74
2021-10
0
3.56
2021-11
0
3.68
2021-12
0
3.95
2022-01
0
4.13
2022-02
0
3.14
2022-03
0
3.34
2022-04
0
3.29
2022-05
0
3.2
2022-06
0
3.7
2022-07
0
3.24
2022-08
0
3.74
2022-09
0
3.72
2022-10
0
4.02
2022-11
0
3.19
2022-12
0
5.17
2023-01
0
3.56
2023-02
0
3.37
2023-03
0
3.8
2023-04
0
3.93
2023-05
0
4.07
2023-06
0
4.54
2023-07
0
3.48
2023-08
0
3.5
2023-09
0
4.11
2023-10
0
4.1
2023-11
0
4.07
2023-12
0
4.71
2024-01
0
4.66
2024-02
0
3.86
2024-03
0
4.01
2024-04
0
4.27
2024-05
0
4.39
2024-06
0
4.72
2024-07
0
3.58
2024-08
0
3.58
2024-09
0
4.03
2024-10
0
4.18
2024-11
0
3.84
2024-12
0
4.27
2025-01
0
4.32
2025-02
0
3.76
2025-03
0
5.1
2025-04
0
4.4
2025-05
0
4.46
2025-06
0
4.38
2025-07
0
4.18
2025-08
0
4.26
2025-09
0
3.89
2025-10
0
4.21
2025-11
0
4.27
2025-12
0
5.53
2026-01
0
4.61
2026-02
0
4.86
2026-03
0
4.99
2026-04
0
4.85
2026-05
0
5.54
2026-06
0
4.87
This device (reports/month)Average device in FZP, HWC, JDR, MAI, MBI, NEU (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