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JARVIS Diaphyseal Stem Standard

Model 272354 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D9 L95 · FOURNITURES HOSPITALIERES INDUSTRIE · DI 03661489723544

HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · Class II · 21 CFR 888.3690

KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660

PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660

UDILibrary device dossier · generated 2026-09-16 · 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.

11232019-01: 0 reports for this device; peer average 1.81/device2019-02: 0 reports for this device; peer average 1.74/device2019-03: 0 reports for this device; peer average 1.72/device2019-04: 0 reports for this device; peer average 1.79/device2019-05: 0 reports for this device; peer average 2.02/device2019-06: 0 reports for this device; peer average 1.86/device2019-07: 0 reports for this device; peer average 1.58/device2019-08: 0 reports for this device; peer average 2.14/device2019-09: 0 reports for this device; peer average 1.65/device2019-10: 0 reports for this device; peer average 1.82/device2019-11: 0 reports for this device; peer average 1.7/device2019-12: 0 reports for this device; peer average 1.74/device2020-01: 0 reports for this device; peer average 1.98/device2020-02: 0 reports for this device; peer average 2.11/device2020-03: 0 reports for this device; peer average 1.99/device2020-04: 0 reports for this device; peer average 1.77/device2020-05: 0 reports for this device; peer average 1.65/device2020-06: 0 reports for this device; peer average 1.92/device2020-07: 0 reports for this device; peer average 2.16/device2020-08: 0 reports for this device; peer average 1.79/device2020-09: 0 reports for this device; peer average 1.97/device2020-10: 0 reports for this device; peer average 2.11/device2020-11: 0 reports for this device; peer average 1.88/device2020-12: 0 reports for this device; peer average 1.84/device2021-01: 0 reports for this device; peer average 2.11/device2021-02: 0 reports for this device; peer average 2.02/device2021-03: 0 reports for this device; peer average 2.13/device2021-04: 0 reports for this device; peer average 2.02/device2021-05: 0 reports for this device; peer average 1.96/device2021-06: 0 reports for this device; peer average 1.8/device2021-07: 0 reports for this device; peer average 2.05/device2021-08: 0 reports for this device; peer average 2.2/device2021-09: 0 reports for this device; peer average 1.94/device2021-10: 0 reports for this device; peer average 2.13/device2021-11: 0 reports for this device; peer average 2.1/device2021-12: 0 reports for this device; peer average 2.39/device2022-01: 0 reports for this device; peer average 2.54/device2022-02: 0 reports for this device; peer average 2.33/device2022-03: 0 reports for this device; peer average 2.38/device2022-04: 0 reports for this device; peer average 2.39/device2022-05: 0 reports for this device; peer average 2.1/device2022-06: 0 reports for this device; peer average 2.2/device2022-07: 0 reports for this device; peer average 2.23/device2022-08: 0 reports for this device; peer average 2.2/device2022-09: 0 reports for this device; peer average 2.01/device2022-10: 0 reports for this device; peer average 2.06/device2022-11: 0 reports for this device; peer average 2.07/device2022-12: 0 reports for this device; peer average 2.01/device2023-01: 0 reports for this device; peer average 1.84/device2023-02: 0 reports for this device; peer average 1.96/device2023-03: 0 reports for this device; peer average 2.05/device2023-04: 0 reports for this device; peer average 2.17/device2023-05: 0 reports for this device; peer average 2.1/device2023-06: 0 reports for this device; peer average 2.27/device2023-07: 0 reports for this device; peer average 2.05/device2023-08: 0 reports for this device; peer average 1.7/device2023-09: 0 reports for this device; peer average 1.52/device2023-10: 0 reports for this device; peer average 1.62/device2023-11: 0 reports for this device; peer average 1.63/device2023-12: 0 reports for this device; peer average 1.43/device2024-01: 0 reports for this device; peer average 1.79/device2024-02: 0 reports for this device; peer average 1.78/device2024-03: 0 reports for this device; peer average 1.66/device2024-04: 0 reports for this device; peer average 1.83/device2024-05: 0 reports for this device; peer average 1.64/device2024-06: 0 reports for this device; peer average 1.88/device2024-07: 0 reports for this device; peer average 1.56/device2024-08: 0 reports for this device; peer average 1.71/device2024-09: 0 reports for this device; peer average 1.67/device2024-10: 0 reports for this device; peer average 1.69/device2024-11: 0 reports for this device; peer average 1.58/device2024-12: 0 reports for this device; peer average 1.6/device2025-01: 0 reports for this device; peer average 1.7/device2025-02: 0 reports for this device; peer average 1.6/device2025-03: 0 reports for this device; peer average 1.88/device2025-04: 0 reports for this device; peer average 1.68/device2025-05: 0 reports for this device; peer average 1.74/device2025-06: 0 reports for this device; peer average 1.87/device2025-07: 0 reports for this device; peer average 1.74/device2025-08: 0 reports for this device; peer average 1.58/device2025-09: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 1.63/device2025-11: 0 reports for this device; peer average 1.75/device2025-12: 0 reports for this device; peer average 2.15/device2026-01: 0 reports for this device; peer average 1.88/device2026-02: 0 reports for this device; peer average 1.83/device2026-03: 0 reports for this device; peer average 1.74/device2026-04: 0 reports for this device; peer average 1.72/device2026-05: 0 reports for this device; peer average 1.72/device2026-06: 0 reports for this device; peer average 1.77/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.81
2019-0201.74
2019-0301.72
2019-0401.79
2019-0502.02
2019-0601.86
2019-0701.58
2019-0802.14
2019-0901.65
2019-1001.82
2019-1101.7
2019-1201.74
2020-0101.98
2020-0202.11
2020-0301.99
2020-0401.77
2020-0501.65
2020-0601.92
2020-0702.16
2020-0801.79
2020-0901.97
2020-1002.11
2020-1101.88
2020-1201.84
2021-0102.11
2021-0202.02
2021-0302.13
2021-0402.02
2021-0501.96
2021-0601.8
2021-0702.05
2021-0802.2
2021-0901.94
2021-1002.13
2021-1102.1
2021-1202.39
2022-0102.54
2022-0202.33
2022-0302.38
2022-0402.39
2022-0502.1
2022-0602.2
2022-0702.23
2022-0802.2
2022-0902.01
2022-1002.06
2022-1102.07
2022-1202.01
2023-0101.84
2023-0201.96
2023-0302.05
2023-0402.17
2023-0502.1
2023-0602.27
2023-0702.05
2023-0801.7
2023-0901.52
2023-1001.62
2023-1101.63
2023-1201.43
2024-0101.79
2024-0201.78
2024-0301.66
2024-0401.83
2024-0501.64
2024-0601.88
2024-0701.56
2024-0801.71
2024-0901.67
2024-1001.69
2024-1101.58
2024-1201.6
2025-0101.7
2025-0201.6
2025-0301.88
2025-0401.68
2025-0501.74
2025-0601.87
2025-0701.74
2025-0801.58
2025-0901.5
2025-1001.63
2025-1101.75
2025-1202.15
2026-0101.88
2026-0201.83
2026-0301.74
2026-0401.72
2026-0501.72
2026-0601.77
This device (reports/month)Average device in HSD, KWS, PHX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K253345 — cites (transitively): K093591 (d1), K112193 (d1), K150568 (d1), K202024 (d1), K042021 (d2), K061454 (d2), K063569 (d2), K073688 (d2), K093599 (d2), K021478 (d2), K060692 (d2), K080642 (d2), K150569 (d2), K162068 (d2), K162726 (d2), K171789 (d2), K190290 (d2), K992065 (d3), K062779 (d3), K030710 (d3), K142778 (d3), K052906 (d3), K120740 (d3), K132285 (d3), K150463 (d3), K150471 (d3), K113413 (d3), K122698 (d3), K141990 (d3), K162024 (d3), K172351 (d3), K071147 (d4), K080974 (d4), K080402 (d4), K082120 (d4), K100741 (d4), K103208 (d4), K111735 (d4), K130048 (d4), K140904 (d4), K950594 (d4), K950651 (d4), K103251 (d4), K070617 (d4), K091788 (d4), K991407 (d4), K123982 (d4), K111061 (d4), K141006 (d4) — cited as predicate by K254003

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

Manufacturer compliance record — FOURNITURES HOSPITALIERES INDUSTRIE

Nothing in the loaded window.