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Vanguard® 360 Instrument

Model 32-360680 · Biomet Orthopedics, LLC · DI 00887868564208

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

MBV — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560

UDILibrary device dossier · generated 2026-09-12 · 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	1.9
2019-02	0	1.96
2019-03	0	1.62
2019-04	0	1.9
2019-05	0	1.73
2019-06	0	2.03
2019-07	0	1.94
2019-08	0	2.11
2019-09	0	1.85
2019-10	0	2.18
2019-11	0	2.72
2019-12	0	2.22
2020-01	0	2.19
2020-02	0	2.52
2020-03	0	2.09
2020-04	0	2.01
2020-05	0	1.7
2020-06	0	1.95
2020-07	0	2.47
2020-08	0	2.52
2020-09	0	2.09
2020-10	0	2.62
2020-11	0	2.56
2020-12	0	2.68
2021-01	0	2.22
2021-02	0	2.22
2021-03	0	2.38
2021-04	0	2.18
2021-05	0	2.15
2021-06	0	2.04
2021-07	0	2.01
2021-08	0	1.75
2021-09	0	2.12
2021-10	0	1.8
2021-11	0	2.07
2021-12	0	2.15
2022-01	0	1.85
2022-02	0	2.2
2022-03	0	1.86
2022-04	0	1.91
2022-05	0	2.1
2022-06	0	1.85
2022-07	0	1.9
2022-08	0	1.93
2022-09	0	2.05
2022-10	0	2.02
2022-11	0	2.1
2022-12	0	1.76
2023-01	0	1.92
2023-02	0	2.05
2023-03	0	2.04
2023-04	0	2.09
2023-05	0	2.22
2023-06	0	2.09
2023-07	0	1.85
2023-08	0	1.59
2023-09	0	1.63
2023-10	0	1.52
2023-11	0	1.58
2023-12	0	1.58
2024-01	0	1.47
2024-02	0	1.62
2024-03	0	1.67
2024-04	0	1.55
2024-05	0	1.75
2024-06	0	1.83
2024-07	0	1.7
2024-08	0	2.15
2024-09	0	1.85
2024-10	0	1.84
2024-11	0	1.8
2024-12	0	1.92
2025-01	0	2.11
2025-02	0	1.7
2025-03	0	1.67
2025-04	0	1.56
2025-05	0	1.61
2025-06	0	1.67
2025-07	0	1.52
2025-08	0	1.56
2025-09	0	1.53
2025-10	0	1.37
2025-11	0	1.58
2025-12	0	1.57
2026-01	0	1.46
2026-02	0	1.46
2026-03	0	1.8
2026-04	0	1.61
2026-05	0	1.59
2026-06	0	1.56

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

Regulatory clearances

None linked in the loaded window.

Predicate lineage

K093293 — cites (transitively): K010212 (d1), K042757 (d1) — cited as predicate by K121149, K122183, K140883, K143192, K181947

K140883 — cites (transitively): K072336 (d1), K093293 (d1), K102896 (d1), K121149 (d1), K010212 (d2), K042757 (d2)

K143192 — cites (transitively): K093293 (d1), K010212 (d2), K042757 (d2)

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

Manufacturer compliance record — Biomet Orthopedics, LLC

Nothing in the loaded window.