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C2 Stem

Model 4510.15.080 · LIMACORPORATE SPA · DI 08033390299275

KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390

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

UDILibrary device dossier · generated 2026-09-06 · 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 (1)

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.

Injury: 1

11232019-01: 0 reports for this device; peer average 2.3/device2019-02: 0 reports for this device; peer average 2.12/device2019-03: 0 reports for this device; peer average 2.35/device2019-04: 0 reports for this device; peer average 2.29/device2019-05: 0 reports for this device; peer average 1.88/device2019-06: 0 reports for this device; peer average 1.66/device2019-07: 0 reports for this device; peer average 1.6/device2019-08: 0 reports for this device; peer average 1.98/device2019-09: 0 reports for this device; peer average 1.9/device2019-10: 0 reports for this device; peer average 2.16/device2019-11: 0 reports for this device; peer average 1.87/device2019-12: 0 reports for this device; peer average 2.14/device2020-01: 0 reports for this device; peer average 2.51/device2020-02: 0 reports for this device; peer average 2.18/device2020-03: 0 reports for this device; peer average 2.64/device2020-04: 0 reports for this device; peer average 2.04/device2020-05: 0 reports for this device; peer average 1.93/device2020-06: 0 reports for this device; peer average 1.84/device2020-07: 0 reports for this device; peer average 2.28/device2020-08: 0 reports for this device; peer average 1.86/device2020-09: 0 reports for this device; peer average 2.27/device2020-10: 0 reports for this device; peer average 2.23/device2020-11: 0 reports for this device; peer average 2.04/device2020-12: 0 reports for this device; peer average 2.16/device2021-01: 0 reports for this device; peer average 2.19/device2021-02: 0 reports for this device; peer average 1.89/device2021-03: 0 reports for this device; peer average 1.9/device2021-04: 0 reports for this device; peer average 1.86/device2021-05: 0 reports for this device; peer average 1.82/device2021-06: 0 reports for this device; peer average 2.18/device2021-07: 0 reports for this device; peer average 2.2/device2021-08: 0 reports for this device; peer average 2.18/device2021-09: 0 reports for this device; peer average 2.33/device2021-10: 0 reports for this device; peer average 2.12/device2021-11: 0 reports for this device; peer average 1.88/device2021-12: 0 reports for this device; peer average 2.09/device2022-01: 0 reports for this device; peer average 1.94/device2022-02: 0 reports for this device; peer average 1.97/device2022-03: 0 reports for this device; peer average 2.02/device2022-04: 1 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 2.12/device2022-06: 0 reports for this device; peer average 2.03/device2022-07: 0 reports for this device; peer average 2.01/device2022-08: 0 reports for this device; peer average 2.09/device2022-09: 0 reports for this device; peer average 2.15/device2022-10: 0 reports for this device; peer average 2.05/device2022-11: 0 reports for this device; peer average 2.13/device2022-12: 0 reports for this device; peer average 2.03/device2023-01: 0 reports for this device; peer average 2.42/device2023-02: 0 reports for this device; peer average 2.04/device2023-03: 0 reports for this device; peer average 2.1/device2023-04: 0 reports for this device; peer average 2.19/device2023-05: 0 reports for this device; peer average 2.07/device2023-06: 0 reports for this device; peer average 2.16/device2023-07: 0 reports for this device; peer average 2.12/device2023-08: 0 reports for this device; peer average 1.93/device2023-09: 0 reports for this device; peer average 1.96/device2023-10: 0 reports for this device; peer average 1.66/device2023-11: 0 reports for this device; peer average 1.63/device2023-12: 0 reports for this device; peer average 1.73/device2024-01: 0 reports for this device; peer average 1.74/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 1.98/device2024-04: 0 reports for this device; peer average 1.78/device2024-05: 0 reports for this device; peer average 2.15/device2024-06: 0 reports for this device; peer average 1.93/device2024-07: 0 reports for this device; peer average 1.71/device2024-08: 0 reports for this device; peer average 1.97/device2024-09: 0 reports for this device; peer average 1.99/device2024-10: 0 reports for this device; peer average 1.77/device2024-11: 0 reports for this device; peer average 1.76/device2024-12: 0 reports for this device; peer average 1.61/device2025-01: 0 reports for this device; peer average 1.91/device2025-02: 0 reports for this device; peer average 1.54/device2025-03: 0 reports for this device; peer average 1.8/device2025-04: 0 reports for this device; peer average 1.83/device2025-05: 0 reports for this device; peer average 1.71/device2025-06: 0 reports for this device; peer average 1.81/device2025-07: 0 reports for this device; peer average 1.83/device2025-08: 0 reports for this device; peer average 1.73/device2025-09: 0 reports for this device; peer average 1.64/device2025-10: 0 reports for this device; peer average 1.74/device2025-11: 0 reports for this device; peer average 1.75/device2025-12: 0 reports for this device; peer average 1.81/device2026-01: 0 reports for this device; peer average 1.9/device2026-02: 0 reports for this device; peer average 1.65/device2026-03: 0 reports for this device; peer average 1.86/device2026-04: 0 reports for this device; peer average 1.86/device2026-05: 0 reports for this device; peer average 1.7/device2026-06: 0 reports for this device; peer average 1.72/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.3
2019-0202.12
2019-0302.35
2019-0402.29
2019-0501.88
2019-0601.66
2019-0701.6
2019-0801.98
2019-0901.9
2019-1002.16
2019-1101.87
2019-1202.14
2020-0102.51
2020-0202.18
2020-0302.64
2020-0402.04
2020-0501.93
2020-0601.84
2020-0702.28
2020-0801.86
2020-0902.27
2020-1002.23
2020-1102.04
2020-1202.16
2021-0102.19
2021-0201.89
2021-0301.9
2021-0401.86
2021-0501.82
2021-0602.18
2021-0702.2
2021-0802.18
2021-0902.33
2021-1002.12
2021-1101.88
2021-1202.09
2022-0101.94
2022-0201.97
2022-0302.02
2022-0412
2022-0502.12
2022-0602.03
2022-0702.01
2022-0802.09
2022-0902.15
2022-1002.05
2022-1102.13
2022-1202.03
2023-0102.42
2023-0202.04
2023-0302.1
2023-0402.19
2023-0502.07
2023-0602.16
2023-0702.12
2023-0801.93
2023-0901.96
2023-1001.66
2023-1101.63
2023-1201.73
2024-0101.74
2024-0202
2024-0301.98
2024-0401.78
2024-0502.15
2024-0601.93
2024-0701.71
2024-0801.97
2024-0901.99
2024-1001.77
2024-1101.76
2024-1201.61
2025-0101.91
2025-0201.54
2025-0301.8
2025-0401.83
2025-0501.71
2025-0601.81
2025-0701.83
2025-0801.73
2025-0901.64
2025-1001.74
2025-1101.75
2025-1201.81
2026-0101.9
2026-0201.65
2026-0301.86
2026-0401.86
2026-0501.7
2026-0601.72
This device (reports/month)Average device in KWY, LWJ, LZO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K170473 — cites (transitively): K030373 (d1), K033664 (d1), K072852 (d1), K100858 (d1), K112091 (d1), K112158 (d1), K120211 (d1), K141934 (d1), K143096 (d1), K150855 (d1), K151739 (d1), K160011 (d1), K962101 (d1), K030259 (d2), K063578 (d2), K992525 (d2), K042992 (d2), K023743 (d2), K023794 (d2), K032380 (d2), K072154 (d2), K091423 (d2), K883460 (d2), K974093 (d2), K974095 (d2), K992153 (d2), K033260 (d2), K093552 (d2), K121443 (d2), K951987 (d2), K122296 (d2), K112898 (d2), K140975 (d2), K141327 (d2), K141395 (d2), K143509 (d2), K031572 (d2), K092331 (d2), K992667 (d2), K130728 (d2), K032709 (d3), K090757 (d3), K994038 (d3), K021891 (d3), K070369 (d3), K102975 (d3), K850766 (d3), K851213 (d3), K934765 (d3), K953490 (d3), K960094 (d3), K042515 (d3), K101499 (d3), K111711 (d3), K113482 (d3), K052792 (d3), K972791 (d3), K043537 (d3), K083762 (d3), K100412 (d3), K130899 (d3), K980513 (d3), K991325 (d3), K071535 (d4), K082844 (d4), K023211 (d4), K040267 (d4), K041825 (d4), K062654 (d4), K070479 (d4), K032295 (d4), K071071 (d4), K073325 (d4), K022204 (d4), K051229 (d4), K946236 (d4), K071723 (d4), K123392 (d4) — cited as predicate by K243809

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

Manufacturer compliance record — LIMACORPORATE SPA

Nothing in the loaded window.