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COMPRESS DEVICE

Model 178754 · Biomet Orthopedics, LLC · DI 00880304554832

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

PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660

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 (1)

Initiated	Recall #	Class	Status	Reason	Link basis
2019-08-21	Z-0519-2020	Class II	Terminated	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.	code info di

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	1.81
2019-02	0	1.75
2019-03	0	1.66
2019-04	0	1.93
2019-05	0	2.08
2019-06	0	1.85
2019-07	0	1.67
2019-08	0	2.15
2019-09	0	1.66
2019-10	0	1.89
2019-11	0	1.63
2019-12	0	1.8
2020-01	0	1.9
2020-02	0	2.04
2020-03	0	2.12
2020-04	0	1.69
2020-05	0	1.67
2020-06	0	2.01
2020-07	0	2.19
2020-08	0	1.82
2020-09	0	2.02
2020-10	0	2.23
2020-11	0	1.88
2020-12	0	1.84
2021-01	0	2.1
2021-02	0	1.86
2021-03	0	2.02
2021-04	0	1.96
2021-05	0	1.89
2021-06	0	1.82
2021-07	0	2
2021-08	0	2.22
2021-09	0	1.91
2021-10	0	2.17
2021-11	0	2.03
2021-12	0	2.43
2022-01	0	2.53
2022-02	0	2.34
2022-03	0	2.4
2022-04	0	2.36
2022-05	0	2.02
2022-06	0	2.25
2022-07	0	2.15
2022-08	0	2.2
2022-09	0	1.98
2022-10	0	1.95
2022-11	0	2.11
2022-12	0	2.01
2023-01	0	1.8
2023-02	0	1.95
2023-03	0	1.94
2023-04	0	2.13
2023-05	0	2
2023-06	0	2.17
2023-07	0	2.04
2023-08	0	1.71
2023-09	0	1.53
2023-10	0	1.59
2023-11	0	1.66
2023-12	0	1.41
2024-01	0	1.82
2024-02	0	1.9
2024-03	0	1.68
2024-04	0	1.82
2024-05	0	1.68
2024-06	0	1.88
2024-07	0	1.61
2024-08	0	1.69
2024-09	0	1.9
2024-10	0	1.69
2024-11	0	1.62
2024-12	0	1.65
2025-01	0	1.7
2025-02	0	1.63
2025-03	0	1.86
2025-04	0	1.75
2025-05	0	1.87
2025-06	0	1.89
2025-07	0	1.71
2025-08	0	1.65
2025-09	0	1.45
2025-10	0	1.63
2025-11	0	1.72
2025-12	0	2.15
2026-01	0	1.88
2026-02	0	1.73
2026-03	0	1.72
2026-04	0	1.72
2026-05	0	1.7
2026-06	0	1.7

This device (reports/month)Average device in JDC, KWS, KWT, MBF, PHX (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

K123297 — cites (transitively): K112905 (d1), K020045 (d2), K033280 (d2), K062998 (d2) — cited as predicate by K183553

K173411 — cites (transitively): K052906 (d1), K060704 (d1), K080642 (d1), K111746 (d1), K112905 (d1), K113069 (d1), K113121 (d1), K120121 (d1), K121543 (d1), K122692 (d1), K130661 (d1), K131353 (d1), K133378 (d1), K143659 (d1), K152754 (d1), K153398 (d1), K020045 (d2), K030710 (d2), K033280 (d2), K042321 (d2), K043505 (d2), K622079 (d2), K925613 (d2), K062998 (d2), K123862 (d2), K001989 (d3) — cited as predicate by K191318, K223631

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Biomet Orthopedics, LLC

Nothing in the loaded window.