H-MAX S Stem
Model 4251.20.140 · LIMACORPORATE SPA · DI 08033390299923
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390
MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.46 |
| 2019-02 | 0 | 2.11 |
| 2019-03 | 0 | 2.29 |
| 2019-04 | 0 | 2.34 |
| 2019-05 | 0 | 1.87 |
| 2019-06 | 0 | 1.59 |
| 2019-07 | 0 | 1.68 |
| 2019-08 | 0 | 1.81 |
| 2019-09 | 0 | 1.89 |
| 2019-10 | 0 | 1.99 |
| 2019-11 | 0 | 1.73 |
| 2019-12 | 0 | 1.89 |
| 2020-01 | 0 | 2.1 |
| 2020-02 | 0 | 2.01 |
| 2020-03 | 0 | 2.56 |
| 2020-04 | 0 | 1.81 |
| 2020-05 | 0 | 1.88 |
| 2020-06 | 0 | 1.67 |
| 2020-07 | 0 | 2.03 |
| 2020-08 | 0 | 1.62 |
| 2020-09 | 0 | 1.84 |
| 2020-10 | 0 | 1.93 |
| 2020-11 | 0 | 1.82 |
| 2020-12 | 0 | 1.85 |
| 2021-01 | 0 | 1.94 |
| 2021-02 | 0 | 1.66 |
| 2021-03 | 0 | 1.69 |
| 2021-04 | 0 | 1.65 |
| 2021-05 | 0 | 1.67 |
| 2021-06 | 0 | 1.95 |
| 2021-07 | 0 | 1.78 |
| 2021-08 | 0 | 1.65 |
| 2021-09 | 0 | 1.88 |
| 2021-10 | 0 | 1.73 |
| 2021-11 | 0 | 1.73 |
| 2021-12 | 0 | 1.83 |
| 2022-01 | 0 | 1.6 |
| 2022-02 | 0 | 1.87 |
| 2022-03 | 0 | 1.61 |
| 2022-04 | 0 | 1.77 |
| 2022-05 | 0 | 1.72 |
| 2022-06 | 0 | 1.76 |
| 2022-07 | 0 | 1.66 |
| 2022-08 | 0 | 1.8 |
| 2022-09 | 0 | 1.77 |
| 2022-10 | 0 | 1.73 |
| 2022-11 | 0 | 1.82 |
| 2022-12 | 0 | 1.64 |
| 2023-01 | 0 | 1.72 |
| 2023-02 | 0 | 1.67 |
| 2023-03 | 0 | 1.76 |
| 2023-04 | 0 | 1.77 |
| 2023-05 | 0 | 1.8 |
| 2023-06 | 0 | 1.87 |
| 2023-07 | 0 | 1.85 |
| 2023-08 | 0 | 1.76 |
| 2023-09 | 0 | 1.82 |
| 2023-10 | 0 | 1.42 |
| 2023-11 | 0 | 1.39 |
| 2023-12 | 0 | 1.43 |
| 2024-01 | 0 | 1.51 |
| 2024-02 | 0 | 1.67 |
| 2024-03 | 0 | 1.83 |
| 2024-04 | 0 | 1.54 |
| 2024-05 | 0 | 1.96 |
| 2024-06 | 0 | 1.74 |
| 2024-07 | 0 | 1.52 |
| 2024-08 | 0 | 1.76 |
| 2024-09 | 0 | 1.78 |
| 2024-10 | 0 | 1.57 |
| 2024-11 | 0 | 1.41 |
| 2024-12 | 0 | 1.42 |
| 2025-01 | 0 | 1.56 |
| 2025-02 | 0 | 1.38 |
| 2025-03 | 0 | 1.68 |
| 2025-04 | 0 | 1.66 |
| 2025-05 | 0 | 1.41 |
| 2025-06 | 0 | 1.64 |
| 2025-07 | 0 | 1.62 |
| 2025-08 | 0 | 1.43 |
| 2025-09 | 0 | 1.59 |
| 2025-10 | 0 | 1.58 |
| 2025-11 | 0 | 1.7 |
| 2025-12 | 0 | 1.74 |
| 2026-01 | 0 | 1.81 |
| 2026-02 | 0 | 1.45 |
| 2026-03 | 0 | 1.9 |
| 2026-04 | 0 | 1.7 |
| 2026-05 | 0 | 1.54 |
| 2026-06 | 0 | 1.55 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K160011 — cites (transitively): K112091 (d1), K130728 (d1), K150855 (d1), K042992 (d2), K052792 (d2), K112158 (d2), K112898 (d2), K140975 (d2), K141327 (d2), K141395 (d2), K143509 (d2), K023743 (d3), K023794 (d3), K032380 (d3), K072154 (d3), K091423 (d3), K883460 (d3), K974093 (d3), K974095 (d3), K992153 (d3), K021891 (d3), K070369 (d3), K102975 (d3), K850766 (d3), K851213 (d3), K934765 (d3), K953490 (d3), K960094 (d3), K972791 (d3), K043537 (d3), K083762 (d3), K100412 (d3), K130899 (d3), K980513 (d3), K991325 (d3), K071535 (d4), K082844 (d4), K070479 (d4), K071723 (d4), K123392 (d4) — cited as predicate by K170473, K243809
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — LIMACORPORATE SPA
Nothing in the loaded window.