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'VANGUARD(TM)

Model 32-489090 · Biomet Orthopedics, LLC · DI 00880304447950

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560

MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer · Class II · 21 CFR 888.3565

OIY — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive · Class II · 21 CFR 888.3560

UDILibrary device dossier · generated 2026-09-07 · 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	2.09
2019-02	0	1.99
2019-03	0	1.64
2019-04	0	1.95
2019-05	0	1.81
2019-06	0	2.04
2019-07	0	2.02
2019-08	0	2.3
2019-09	0	1.99
2019-10	0	2.47
2019-11	0	3.15
2019-12	0	2.39
2020-01	0	2.37
2020-02	0	2.49
2020-03	0	2.11
2020-04	0	1.98
2020-05	0	1.67
2020-06	0	1.94
2020-07	0	2.39
2020-08	0	2.39
2020-09	0	2.05
2020-10	0	2.55
2020-11	0	2.53
2020-12	0	2.57
2021-01	0	2.15
2021-02	0	2.18
2021-03	0	2.31
2021-04	0	2.16
2021-05	0	2.15
2021-06	0	2.05
2021-07	0	2.03
2021-08	0	1.77
2021-09	0	2.08
2021-10	0	1.8
2021-11	0	2.01
2021-12	0	2.12
2022-01	0	1.82
2022-02	0	2.1
2022-03	0	1.84
2022-04	0	1.9
2022-05	0	2.04
2022-06	0	1.82
2022-07	0	1.86
2022-08	0	1.9
2022-09	0	2.03
2022-10	0	1.94
2022-11	0	2.04
2022-12	0	1.71
2023-01	0	1.86
2023-02	0	1.99
2023-03	0	1.96
2023-04	0	2.01
2023-05	0	2.1
2023-06	0	2
2023-07	0	1.78
2023-08	0	1.55
2023-09	0	1.57
2023-10	0	1.47
2023-11	0	1.53
2023-12	0	1.55
2024-01	0	1.43
2024-02	0	1.59
2024-03	0	1.62
2024-04	0	1.51
2024-05	0	1.68
2024-06	0	1.75
2024-07	0	1.62
2024-08	0	2.05
2024-09	0	1.77
2024-10	0	1.79
2024-11	0	1.72
2024-12	0	1.8
2025-01	0	1.99
2025-02	0	1.64
2025-03	0	1.6
2025-04	0	1.51
2025-05	0	1.56
2025-06	0	1.61
2025-07	0	1.49
2025-08	0	1.5
2025-09	0	1.48
2025-10	0	1.34
2025-11	0	1.52
2025-12	0	1.56
2026-01	0	1.46
2026-02	0	1.42
2026-03	0	1.7
2026-04	0	1.56
2026-05	0	1.52
2026-06	0	1.52

This device (reports/month)Average device in JWH, MBH, OIY (reports/device/month)

Regulatory clearances

None linked in the loaded window.

Predicate lineage

K113550 — cites (transitively): K033489 (d1), K050222 (d1), K060303 (d1), K080528 (d1) — cited as predicate by K141407, K151266, K152008, K153657, K171054, K180493, K183583, K190122, K193284, K201084, K221479, K222380, K223548

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

Manufacturer compliance record — Biomet Orthopedics, LLC

Nothing in the loaded window.