Arcos® One-piece Revision System
Model 11-304111 · Biomet Orthopedics, LLC · DI 00880304683136
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
KWL — Prosthesis, Hip, Hemi-, Femoral, Metal · Class II · 21 CFR 888.3360
KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390
KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer · Class II · 21 CFR 888.3310
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3360
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353
OQG — Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented · Class II · 21 CFR 888.3358
OQH — Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented · Class II · 21 CFR 888.3350
OQI — Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented · Class II · 21 CFR 888.3353
PBI — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive · Class II · 21 CFR 888.3310
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.82 |
| 2019-02 | 0 | 2.43 |
| 2019-03 | 0 | 2.74 |
| 2019-04 | 0 | 2.6 |
| 2019-05 | 0 | 2.08 |
| 2019-06 | 0 | 1.77 |
| 2019-07 | 0 | 1.79 |
| 2019-08 | 0 | 2.04 |
| 2019-09 | 0 | 2.23 |
| 2019-10 | 0 | 2.43 |
| 2019-11 | 0 | 2.01 |
| 2019-12 | 0 | 2.31 |
| 2020-01 | 0 | 2.6 |
| 2020-02 | 0 | 2.38 |
| 2020-03 | 0 | 2.98 |
| 2020-04 | 0 | 2.08 |
| 2020-05 | 0 | 2.1 |
| 2020-06 | 0 | 1.91 |
| 2020-07 | 0 | 2.33 |
| 2020-08 | 0 | 1.87 |
| 2020-09 | 0 | 2.34 |
| 2020-10 | 0 | 2.32 |
| 2020-11 | 0 | 2.16 |
| 2020-12 | 0 | 2.2 |
| 2021-01 | 0 | 2.29 |
| 2021-02 | 0 | 1.91 |
| 2021-03 | 0 | 1.94 |
| 2021-04 | 0 | 1.91 |
| 2021-05 | 0 | 1.87 |
| 2021-06 | 0 | 2.33 |
| 2021-07 | 0 | 2.18 |
| 2021-08 | 0 | 2.12 |
| 2021-09 | 0 | 2.24 |
| 2021-10 | 0 | 2.06 |
| 2021-11 | 0 | 1.94 |
| 2021-12 | 0 | 2.15 |
| 2022-01 | 0 | 1.93 |
| 2022-02 | 0 | 1.91 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 2.01 |
| 2022-05 | 0 | 1.99 |
| 2022-06 | 0 | 2.07 |
| 2022-07 | 0 | 1.98 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 2.01 |
| 2022-10 | 0 | 1.99 |
| 2022-11 | 0 | 2.05 |
| 2022-12 | 0 | 2.02 |
| 2023-01 | 0 | 2.1 |
| 2023-02 | 0 | 1.93 |
| 2023-03 | 0 | 2.15 |
| 2023-04 | 0 | 2.1 |
| 2023-05 | 0 | 2.01 |
| 2023-06 | 0 | 2.04 |
| 2023-07 | 0 | 1.96 |
| 2023-08 | 0 | 1.86 |
| 2023-09 | 0 | 1.85 |
| 2023-10 | 0 | 1.57 |
| 2023-11 | 0 | 1.55 |
| 2023-12 | 0 | 1.64 |
| 2024-01 | 0 | 1.69 |
| 2024-02 | 0 | 1.89 |
| 2024-03 | 0 | 1.88 |
| 2024-04 | 0 | 1.69 |
| 2024-05 | 0 | 1.95 |
| 2024-06 | 0 | 1.81 |
| 2024-07 | 0 | 1.68 |
| 2024-08 | 0 | 1.79 |
| 2024-09 | 0 | 1.89 |
| 2024-10 | 0 | 1.69 |
| 2024-11 | 0 | 1.65 |
| 2024-12 | 0 | 1.5 |
| 2025-01 | 0 | 1.78 |
| 2025-02 | 0 | 1.46 |
| 2025-03 | 0 | 1.72 |
| 2025-04 | 0 | 1.74 |
| 2025-05 | 0 | 1.62 |
| 2025-06 | 0 | 1.76 |
| 2025-07 | 0 | 1.75 |
| 2025-08 | 0 | 1.6 |
| 2025-09 | 0 | 1.68 |
| 2025-10 | 0 | 1.68 |
| 2025-11 | 0 | 1.72 |
| 2025-12 | 0 | 1.81 |
| 2026-01 | 0 | 1.86 |
| 2026-02 | 0 | 1.55 |
| 2026-03 | 0 | 1.85 |
| 2026-04 | 0 | 1.82 |
| 2026-05 | 0 | 1.61 |
| 2026-06 | 0 | 1.65 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K151603 — cites (transitively): K000760 (d1), K070274 (d1), K090757 (d1), K143009 (d1), K150503 (d1), K050251 (d2), K110400 (d2), K130610 (d2), K133184 (d2), K062994 (d3), K071723 (d3), K101086 (d3), K103755 (d3), K052639 (d3), K960658 (d3), K073202 (d3)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC
Nothing in the loaded window.