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H-MAX S Lateralizing

Model Uncemented Stem · LIMACORPORATE SPA · DI 08033390051699

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

LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358

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.

12232019-01: 0 reports for this device; peer average 3.01/device2019-02: 0 reports for this device; peer average 2.56/device2019-03: 0 reports for this device; peer average 2.88/device2019-04: 0 reports for this device; peer average 2.76/device2019-05: 0 reports for this device; peer average 2.15/device2019-06: 0 reports for this device; peer average 1.82/device2019-07: 0 reports for this device; peer average 1.87/device2019-08: 0 reports for this device; peer average 2.09/device2019-09: 0 reports for this device; peer average 2.38/device2019-10: 0 reports for this device; peer average 2.53/device2019-11: 0 reports for this device; peer average 2.11/device2019-12: 0 reports for this device; peer average 2.37/device2020-01: 0 reports for this device; peer average 2.69/device2020-02: 0 reports for this device; peer average 2.45/device2020-03: 0 reports for this device; peer average 3.15/device2020-04: 0 reports for this device; peer average 2.19/device2020-05: 0 reports for this device; peer average 2.16/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2.42/device2020-08: 0 reports for this device; peer average 1.93/device2020-09: 0 reports for this device; peer average 2.38/device2020-10: 0 reports for this device; peer average 2.37/device2020-11: 0 reports for this device; peer average 2.23/device2020-12: 0 reports for this device; peer average 2.21/device2021-01: 0 reports for this device; peer average 2.38/device2021-02: 0 reports for this device; peer average 1.95/device2021-03: 0 reports for this device; peer average 1.95/device2021-04: 0 reports for this device; peer average 1.98/device2021-05: 0 reports for this device; peer average 1.89/device2021-06: 0 reports for this device; peer average 2.42/device2021-07: 0 reports for this device; peer average 2.16/device2021-08: 0 reports for this device; peer average 2.12/device2021-09: 0 reports for this device; peer average 2.22/device2021-10: 0 reports for this device; peer average 2.06/device2021-11: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 2.21/device2022-01: 0 reports for this device; peer average 1.94/device2022-02: 0 reports for this device; peer average 1.99/device2022-03: 0 reports for this device; peer average 2.03/device2022-04: 0 reports for this device; peer average 2.06/device2022-05: 0 reports for this device; peer average 1.97/device2022-06: 0 reports for this device; peer average 2.16/device2022-07: 0 reports for this device; peer average 1.96/device2022-08: 0 reports for this device; peer average 2.08/device2022-09: 0 reports for this device; peer average 2.06/device2022-10: 0 reports for this device; peer average 2.02/device2022-11: 0 reports for this device; peer average 2.1/device2022-12: 0 reports for this device; peer average 2.02/device2023-01: 0 reports for this device; peer average 2.1/device2023-02: 0 reports for this device; peer average 2.03/device2023-03: 0 reports for this device; peer average 2.24/device2023-04: 0 reports for this device; peer average 2.14/device2023-05: 0 reports for this device; peer average 2.1/device2023-06: 0 reports for this device; peer average 2.17/device2023-07: 0 reports for this device; peer average 2.03/device2023-08: 0 reports for this device; peer average 1.93/device2023-09: 0 reports for this device; peer average 1.95/device2023-10: 0 reports for this device; peer average 1.61/device2023-11: 0 reports for this device; peer average 1.55/device2023-12: 0 reports for this device; peer average 1.63/device2024-01: 0 reports for this device; peer average 1.68/device2024-02: 0 reports for this device; peer average 1.97/device2024-03: 0 reports for this device; peer average 1.94/device2024-04: 0 reports for this device; peer average 1.7/device2024-05: 0 reports for this device; peer average 2.04/device2024-06: 0 reports for this device; peer average 1.88/device2024-07: 0 reports for this device; peer average 1.67/device2024-08: 0 reports for this device; peer average 1.85/device2024-09: 0 reports for this device; peer average 1.99/device2024-10: 0 reports for this device; peer average 1.75/device2024-11: 0 reports for this device; peer average 1.63/device2024-12: 0 reports for this device; peer average 1.52/device2025-01: 0 reports for this device; peer average 1.81/device2025-02: 0 reports for this device; peer average 1.48/device2025-03: 0 reports for this device; peer average 1.76/device2025-04: 0 reports for this device; peer average 1.76/device2025-05: 0 reports for this device; peer average 1.61/device2025-06: 0 reports for this device; peer average 1.77/device2025-07: 0 reports for this device; peer average 1.77/device2025-08: 0 reports for this device; peer average 1.6/device2025-09: 0 reports for this device; peer average 1.71/device2025-10: 0 reports for this device; peer average 1.66/device2025-11: 0 reports for this device; peer average 1.76/device2025-12: 0 reports for this device; peer average 1.84/device2026-01: 0 reports for this device; peer average 1.93/device2026-02: 0 reports for this device; peer average 1.56/device2026-03: 0 reports for this device; peer average 1.95/device2026-04: 0 reports for this device; peer average 1.8/device2026-05: 0 reports for this device; peer average 1.61/device2026-06: 0 reports for this device; peer average 1.68/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.01
2019-0202.56
2019-0302.88
2019-0402.76
2019-0502.15
2019-0601.82
2019-0701.87
2019-0802.09
2019-0902.38
2019-1002.53
2019-1102.11
2019-1202.37
2020-0102.69
2020-0202.45
2020-0303.15
2020-0402.19
2020-0502.16
2020-0602
2020-0702.42
2020-0801.93
2020-0902.38
2020-1002.37
2020-1102.23
2020-1202.21
2021-0102.38
2021-0201.95
2021-0301.95
2021-0401.98
2021-0501.89
2021-0602.42
2021-0702.16
2021-0802.12
2021-0902.22
2021-1002.06
2021-1102
2021-1202.21
2022-0101.94
2022-0201.99
2022-0302.03
2022-0402.06
2022-0501.97
2022-0602.16
2022-0701.96
2022-0802.08
2022-0902.06
2022-1002.02
2022-1102.1
2022-1202.02
2023-0102.1
2023-0202.03
2023-0302.24
2023-0402.14
2023-0502.1
2023-0602.17
2023-0702.03
2023-0801.93
2023-0901.95
2023-1001.61
2023-1101.55
2023-1201.63
2024-0101.68
2024-0201.97
2024-0301.94
2024-0401.7
2024-0502.04
2024-0601.88
2024-0701.67
2024-0801.85
2024-0901.99
2024-1001.75
2024-1101.63
2024-1201.52
2025-0101.81
2025-0201.48
2025-0301.76
2025-0401.76
2025-0501.61
2025-0601.77
2025-0701.77
2025-0801.6
2025-0901.71
2025-1001.66
2025-1101.76
2025-1201.84
2026-0101.93
2026-0201.56
2026-0301.95
2026-0401.8
2026-0501.61
2026-0601.68
This device (reports/month)Average device in JDI, KWY, LPH, MEH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K112091 — cites (transitively): K042992 (d1) — cited as predicate by K141327, K150855, K160011, K170473, K243809

K150855 — cites (transitively): K112091 (d1), K112158 (d1), K112898 (d1), K140975 (d1), K141327 (d1), K141395 (d1), K143509 (d1), K042992 (d2), K023743 (d2), K023794 (d2), K032380 (d2), K072154 (d2), K091423 (d2), K883460 (d2), K974093 (d2), K974095 (d2), K992153 (d2), K021891 (d2), K070369 (d2), K102975 (d2), K850766 (d2), K851213 (d2), K934765 (d2), K953490 (d2), K960094 (d2), K972791 (d2), K043537 (d2), K083762 (d2), K100412 (d2), K130899 (d2), K980513 (d2), K991325 (d2), K071535 (d3), K082844 (d3), K070479 (d3), K071723 (d3), K123392 (d3) — cited as predicate by K160011, K170473, K243809

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.