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SCREW SYSTEM
Model 113848 · Biomet Orthopedics, LLC · DI 00880304213999
HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · Class II · 21 CFR 888.3690
KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660
KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3670
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
3.25
2019-02
0
2.76
2019-03
0
3.15
2019-04
0
2.88
2019-05
0
2.37
2019-06
0
2.03
2019-07
0
1.9
2019-08
0
2.34
2019-09
0
2.55
2019-10
0
2.74
2019-11
0
2.22
2019-12
0
2.51
2020-01
0
3
2020-02
0
2.7
2020-03
0
3.22
2020-04
0
2.31
2020-05
0
2.21
2020-06
0
2.34
2020-07
0
2.55
2020-08
0
2.19
2020-09
0
2.62
2020-10
0
2.68
2020-11
0
2.44
2020-12
0
2.33
2021-01
0
2.53
2021-02
0
2.15
2021-03
0
2.2
2021-04
0
2.25
2021-05
0
2.02
2021-06
0
2.45
2021-07
0
2.39
2021-08
0
2.57
2021-09
0
2.4
2021-10
0
2.31
2021-11
0
2.21
2021-12
0
2.38
2022-01
0
2.33
2022-02
0
2.17
2022-03
0
2.33
2022-04
0
2.29
2022-05
0
2.12
2022-06
0
2.47
2022-07
0
2.29
2022-08
0
2.32
2022-09
0
2.17
2022-10
0
2.14
2022-11
0
2.26
2022-12
0
2.19
2023-01
0
2.2
2023-02
0
2.2
2023-03
0
2.42
2023-04
0
2.31
2023-05
0
2.18
2023-06
0
2.33
2023-07
0
2.14
2023-08
0
1.89
2023-09
0
1.75
2023-10
0
1.69
2023-11
0
1.68
2023-12
0
1.6
2024-01
0
1.83
2024-02
0
2.01
2024-03
0
1.76
2024-04
0
1.82
2024-05
0
1.86
2024-06
0
1.95
2024-07
0
1.69
2024-08
0
1.8
2024-09
0
1.93
2024-10
0
1.77
2024-11
0
1.73
2024-12
0
1.62
2025-01
0
1.86
2025-02
0
1.59
2025-03
0
1.81
2025-04
0
1.76
2025-05
0
1.81
2025-06
0
1.85
2025-07
0
1.75
2025-08
0
1.69
2025-09
0
1.62
2025-10
0
1.62
2025-11
0
1.77
2025-12
0
2.06
2026-01
0
1.89
2026-02
0
1.7
2026-03
0
1.78
2026-04
0
1.79
2026-05
0
1.64
2026-06
0
1.71
This device (reports/month)Average device in HSD, KWS, KWT, LPH, MBF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K030710 — cited as predicate by K111746, K140390, K143256, K162068, K163397, K211729
K992119 — cited as predicate by K211729
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC