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BIOMET KNEE SYSTEM

Model 141485 · Biomet Orthopedics, LLC · DI 00880304009974

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 2026-09-14 · 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.

12232019-01: 0 reports for this device; peer average 2.07/device2019-02: 0 reports for this device; peer average 1.98/device2019-03: 0 reports for this device; peer average 1.62/device2019-04: 0 reports for this device; peer average 1.93/device2019-05: 0 reports for this device; peer average 1.8/device2019-06: 0 reports for this device; peer average 2.03/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 2.26/device2019-09: 0 reports for this device; peer average 1.96/device2019-10: 0 reports for this device; peer average 2.39/device2019-11: 0 reports for this device; peer average 3.08/device2019-12: 0 reports for this device; peer average 2.38/device2020-01: 0 reports for this device; peer average 2.31/device2020-02: 0 reports for this device; peer average 2.43/device2020-03: 0 reports for this device; peer average 2.13/device2020-04: 0 reports for this device; peer average 1.98/device2020-05: 0 reports for this device; peer average 1.66/device2020-06: 0 reports for this device; peer average 2.08/device2020-07: 0 reports for this device; peer average 2.55/device2020-08: 0 reports for this device; peer average 2.6/device2020-09: 0 reports for this device; peer average 2.22/device2020-10: 0 reports for this device; peer average 2.73/device2020-11: 0 reports for this device; peer average 2.78/device2020-12: 0 reports for this device; peer average 3.01/device2021-01: 0 reports for this device; peer average 2.39/device2021-02: 0 reports for this device; peer average 2.48/device2021-03: 0 reports for this device; peer average 2.35/device2021-04: 0 reports for this device; peer average 2.18/device2021-05: 0 reports for this device; peer average 2.5/device2021-06: 0 reports for this device; peer average 2.28/device2021-07: 0 reports for this device; peer average 2.21/device2021-08: 0 reports for this device; peer average 1.95/device2021-09: 0 reports for this device; peer average 2.39/device2021-10: 0 reports for this device; peer average 1.91/device2021-11: 0 reports for this device; peer average 2.16/device2021-12: 0 reports for this device; peer average 2.31/device2022-01: 0 reports for this device; peer average 1.97/device2022-02: 0 reports for this device; peer average 2.31/device2022-03: 0 reports for this device; peer average 2.09/device2022-04: 0 reports for this device; peer average 2.08/device2022-05: 0 reports for this device; peer average 2.42/device2022-06: 0 reports for this device; peer average 1.91/device2022-07: 0 reports for this device; peer average 2.05/device2022-08: 0 reports for this device; peer average 1.99/device2022-09: 0 reports for this device; peer average 2.08/device2022-10: 0 reports for this device; peer average 2.1/device2022-11: 0 reports for this device; peer average 2.14/device2022-12: 0 reports for this device; peer average 1.81/device2023-01: 0 reports for this device; peer average 1.95/device2023-02: 0 reports for this device; peer average 2.05/device2023-03: 0 reports for this device; peer average 1.99/device2023-04: 0 reports for this device; peer average 2.1/device2023-05: 0 reports for this device; peer average 2.14/device2023-06: 0 reports for this device; peer average 2.09/device2023-07: 0 reports for this device; peer average 1.81/device2023-08: 0 reports for this device; peer average 1.59/device2023-09: 0 reports for this device; peer average 1.58/device2023-10: 0 reports for this device; peer average 1.5/device2023-11: 0 reports for this device; peer average 1.6/device2023-12: 0 reports for this device; peer average 1.57/device2024-01: 0 reports for this device; peer average 1.49/device2024-02: 0 reports for this device; peer average 1.63/device2024-03: 0 reports for this device; peer average 1.66/device2024-04: 0 reports for this device; peer average 1.56/device2024-05: 0 reports for this device; peer average 1.68/device2024-06: 0 reports for this device; peer average 1.78/device2024-07: 0 reports for this device; peer average 1.66/device2024-08: 0 reports for this device; peer average 2.07/device2024-09: 0 reports for this device; peer average 1.8/device2024-10: 0 reports for this device; peer average 1.8/device2024-11: 0 reports for this device; peer average 1.73/device2024-12: 0 reports for this device; peer average 1.85/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 1.66/device2025-03: 0 reports for this device; peer average 1.62/device2025-04: 0 reports for this device; peer average 1.54/device2025-05: 0 reports for this device; peer average 1.59/device2025-06: 0 reports for this device; peer average 1.61/device2025-07: 0 reports for this device; peer average 1.52/device2025-08: 0 reports for this device; peer average 1.52/device2025-09: 0 reports for this device; peer average 1.52/device2025-10: 0 reports for this device; peer average 1.38/device2025-11: 0 reports for this device; peer average 1.54/device2025-12: 0 reports for this device; peer average 1.59/device2026-01: 0 reports for this device; peer average 1.46/device2026-02: 0 reports for this device; peer average 1.46/device2026-03: 0 reports for this device; peer average 1.73/device2026-04: 0 reports for this device; peer average 1.57/device2026-05: 0 reports for this device; peer average 1.57/device2026-06: 0 reports for this device; peer average 1.53/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.07
2019-0201.98
2019-0301.62
2019-0401.93
2019-0501.8
2019-0602.03
2019-0702
2019-0802.26
2019-0901.96
2019-1002.39
2019-1103.08
2019-1202.38
2020-0102.31
2020-0202.43
2020-0302.13
2020-0401.98
2020-0501.66
2020-0602.08
2020-0702.55
2020-0802.6
2020-0902.22
2020-1002.73
2020-1102.78
2020-1203.01
2021-0102.39
2021-0202.48
2021-0302.35
2021-0402.18
2021-0502.5
2021-0602.28
2021-0702.21
2021-0801.95
2021-0902.39
2021-1001.91
2021-1102.16
2021-1202.31
2022-0101.97
2022-0202.31
2022-0302.09
2022-0402.08
2022-0502.42
2022-0601.91
2022-0702.05
2022-0801.99
2022-0902.08
2022-1002.1
2022-1102.14
2022-1201.81
2023-0101.95
2023-0202.05
2023-0301.99
2023-0402.1
2023-0502.14
2023-0602.09
2023-0701.81
2023-0801.59
2023-0901.58
2023-1001.5
2023-1101.6
2023-1201.57
2024-0101.49
2024-0201.63
2024-0301.66
2024-0401.56
2024-0501.68
2024-0601.78
2024-0701.66
2024-0802.07
2024-0901.8
2024-1001.8
2024-1101.73
2024-1201.85
2025-0102
2025-0201.66
2025-0301.62
2025-0401.54
2025-0501.59
2025-0601.61
2025-0701.52
2025-0801.52
2025-0901.52
2025-1001.38
2025-1101.54
2025-1201.59
2026-0101.46
2026-0201.46
2026-0301.73
2026-0401.57
2026-0501.57
2026-0601.53
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

K010212 — cited as predicate by K093293, K103837, K142933, K171054

K142933 — cites (transitively): K010212 (d1), K033489 (d1), K915132 (d1) — cited as predicate by 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.