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REGENEREX

Model 141269 · Biomet Orthopedics, LLC · DI 00880304479920

HRY — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3530

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

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

UDILibrary device dossier · generated 2026-09-11 · 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	2.07
2019-02	0	1.98
2019-03	0	1.62
2019-04	0	1.93
2019-05	0	1.8
2019-06	0	2.03
2019-07	0	2
2019-08	0	2.26
2019-09	0	1.96
2019-10	0	2.39
2019-11	0	3.08
2019-12	0	2.38
2020-01	0	2.31
2020-02	0	2.43
2020-03	0	2.13
2020-04	0	1.98
2020-05	0	1.66
2020-06	0	2.08
2020-07	0	2.55
2020-08	0	2.6
2020-09	0	2.22
2020-10	0	2.73
2020-11	0	2.78
2020-12	0	3.01
2021-01	0	2.39
2021-02	0	2.48
2021-03	0	2.35
2021-04	0	2.18
2021-05	0	2.5
2021-06	0	2.28
2021-07	0	2.21
2021-08	0	1.95
2021-09	0	2.39
2021-10	0	1.91
2021-11	0	2.16
2021-12	0	2.31
2022-01	0	1.97
2022-02	0	2.31
2022-03	0	2.09
2022-04	0	2.08
2022-05	0	2.42
2022-06	0	1.91
2022-07	0	2.05
2022-08	0	1.99
2022-09	0	2.08
2022-10	0	2.1
2022-11	0	2.14
2022-12	0	1.81
2023-01	0	1.95
2023-02	0	2.05
2023-03	0	1.99
2023-04	0	2.1
2023-05	0	2.14
2023-06	0	2.09
2023-07	0	1.81
2023-08	0	1.59
2023-09	0	1.58
2023-10	0	1.5
2023-11	0	1.6
2023-12	0	1.57
2024-01	0	1.49
2024-02	0	1.63
2024-03	0	1.66
2024-04	0	1.56
2024-05	0	1.68
2024-06	0	1.78
2024-07	0	1.66
2024-08	0	2.07
2024-09	0	1.8
2024-10	0	1.8
2024-11	0	1.73
2024-12	0	1.85
2025-01	0	2
2025-02	0	1.66
2025-03	0	1.62
2025-04	0	1.54
2025-05	0	1.59
2025-06	0	1.61
2025-07	0	1.52
2025-08	0	1.52
2025-09	0	1.52
2025-10	0	1.38
2025-11	0	1.54
2025-12	0	1.59
2026-01	0	1.46
2026-02	0	1.46
2026-03	0	1.73
2026-04	0	1.57
2026-05	0	1.57
2026-06	0	1.53

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

Regulatory clearances

None linked in the loaded window.

Predicate lineage

K080361 — cited as predicate by K101994, K171054

K171054 — cites (transitively): K010212 (d1), K033489 (d1), K040770 (d1), K042757 (d1), K060525 (d1), K080204 (d1), K080361 (d1), K083782 (d1), K102125 (d1), K110362 (d1), K113550 (d1), K121149 (d1), K140902 (d1), K142933 (d1), K912245 (d1), K915132 (d1), K921182 (d1), K960856 (d1), K993159 (d1), K023546 (d2), K051977 (d2), K050222 (d2), K060303 (d2), K080528 (d2), K093293 (d2) — cited as predicate by K181947

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

Manufacturer compliance record — Biomet Orthopedics, LLC

Nothing in the loaded window.