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Compress®
Model CP461502 · Biomet Orthopedics, LLC · DI 00880304658462
JDC — Prosthesis, Elbow, Constrained, Cemented · Class II · 21 CFR 888.3150
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
MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3670
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
1.72
2019-02
0
1.53
2019-03
0
1.58
2019-04
0
1.7
2019-05
0
1.82
2019-06
0
1.83
2019-07
0
1.45
2019-08
0
1.96
2019-09
0
1.51
2019-10
0
1.84
2019-11
0
1.51
2019-12
0
1.79
2020-01
0
1.83
2020-02
0
2.06
2020-03
0
1.74
2020-04
0
1.58
2020-05
0
1.5
2020-06
0
1.95
2020-07
0
1.89
2020-08
0
1.77
2020-09
0
2.02
2020-10
0
2.17
2020-11
0
1.82
2020-12
0
1.79
2021-01
0
1.85
2021-02
0
1.7
2021-03
0
1.85
2021-04
0
1.76
2021-05
0
1.63
2021-06
0
1.57
2021-07
0
1.85
2021-08
0
2.12
2021-09
0
1.69
2021-10
0
1.81
2021-11
0
1.88
2021-12
0
1.95
2022-01
0
2.03
2022-02
0
2.11
2022-03
0
1.85
2022-04
0
2
2022-05
0
1.8
2022-06
0
2.1
2022-07
0
2.01
2022-08
0
1.98
2022-09
0
1.82
2022-10
0
1.71
2022-11
0
1.98
2022-12
0
1.78
2023-01
0
1.7
2023-02
0
1.81
2023-03
0
1.81
2023-04
0
1.86
2023-05
0
1.86
2023-06
0
2.05
2023-07
0
1.98
2023-08
0
1.62
2023-09
0
1.46
2023-10
0
1.52
2023-11
0
1.6
2023-12
0
1.36
2024-01
0
1.85
2024-02
0
1.8
2024-03
0
1.62
2024-04
0
1.73
2024-05
0
1.65
2024-06
0
1.88
2024-07
0
1.57
2024-08
0
1.65
2024-09
0
1.95
2024-10
0
1.6
2024-11
0
1.58
2024-12
0
1.62
2025-01
0
1.68
2025-02
0
1.56
2025-03
0
1.76
2025-04
0
1.69
2025-05
0
1.83
2025-06
0
1.79
2025-07
0
1.62
2025-08
0
1.61
2025-09
0
1.41
2025-10
0
1.56
2025-11
0
1.69
2025-12
0
2.09
2026-01
0
1.82
2026-02
0
1.65
2026-03
0
1.64
2026-04
0
1.69
2026-05
0
1.63
2026-06
0
1.59
This device (reports/month)Average device in JDC, KWS, KWT, MBF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K112905 — cites (transitively): K020045 (d1), K033280 (d1), K062998 (d1) — cited as predicate by K123297, K173411, K183553
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC