DELTA XTEND
Model 130742203 · DEPUY (IRELAND) · DI 10603295027539
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
UDILibrary device dossier · generated 2026-09-12 · 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 (91)
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: 87 · Malfunction: 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.71 |
| 2019-02 | 1 | 1.54 |
| 2019-03 | 1 | 1.66 |
| 2019-04 | 1 | 1.53 |
| 2019-05 | 4 | 1.78 |
| 2019-06 | 0 | 1.84 |
| 2019-07 | 1 | 1.38 |
| 2019-08 | 2 | 1.99 |
| 2019-09 | 0 | 1.51 |
| 2019-10 | 2 | 1.76 |
| 2019-11 | 0 | 1.63 |
| 2019-12 | 0 | 1.72 |
| 2020-01 | 0 | 1.95 |
| 2020-02 | 0 | 2.16 |
| 2020-03 | 2 | 1.64 |
| 2020-04 | 2 | 1.7 |
| 2020-05 | 1 | 1.51 |
| 2020-06 | 0 | 1.83 |
| 2020-07 | 2 | 1.94 |
| 2020-08 | 0 | 1.73 |
| 2020-09 | 1 | 1.95 |
| 2020-10 | 2 | 2 |
| 2020-11 | 0 | 1.83 |
| 2020-12 | 1 | 1.79 |
| 2021-01 | 2 | 1.93 |
| 2021-02 | 0 | 1.92 |
| 2021-03 | 3 | 2.02 |
| 2021-04 | 0 | 1.87 |
| 2021-05 | 0 | 1.78 |
| 2021-06 | 0 | 1.58 |
| 2021-07 | 0 | 1.92 |
| 2021-08 | 0 | 2.1 |
| 2021-09 | 1 | 1.74 |
| 2021-10 | 0 | 1.82 |
| 2021-11 | 0 | 1.99 |
| 2021-12 | 2 | 1.92 |
| 2022-01 | 0 | 2.14 |
| 2022-02 | 3 | 2.1 |
| 2022-03 | 1 | 1.77 |
| 2022-04 | 0 | 2.07 |
| 2022-05 | 2 | 1.93 |
| 2022-06 | 2 | 2.03 |
| 2022-07 | 1 | 2.15 |
| 2022-08 | 0 | 1.98 |
| 2022-09 | 1 | 1.88 |
| 2022-10 | 2 | 1.87 |
| 2022-11 | 0 | 1.93 |
| 2022-12 | 1 | 1.81 |
| 2023-01 | 1 | 1.75 |
| 2023-02 | 1 | 1.83 |
| 2023-03 | 0 | 1.96 |
| 2023-04 | 0 | 1.94 |
| 2023-05 | 1 | 2.01 |
| 2023-06 | 3 | 2.21 |
| 2023-07 | 3 | 2 |
| 2023-08 | 0 | 1.61 |
| 2023-09 | 0 | 1.44 |
| 2023-10 | 0 | 1.57 |
| 2023-11 | 1 | 1.56 |
| 2023-12 | 1 | 1.39 |
| 2024-01 | 1 | 1.81 |
| 2024-02 | 2 | 1.64 |
| 2024-03 | 1 | 1.59 |
| 2024-04 | 4 | 1.74 |
| 2024-05 | 0 | 1.59 |
| 2024-06 | 3 | 1.88 |
| 2024-07 | 0 | 1.5 |
| 2024-08 | 1 | 1.68 |
| 2024-09 | 2 | 1.61 |
| 2024-10 | 0 | 1.59 |
| 2024-11 | 0 | 1.51 |
| 2024-12 | 2 | 1.55 |
| 2025-01 | 1 | 1.67 |
| 2025-02 | 1 | 1.52 |
| 2025-03 | 1 | 1.78 |
| 2025-04 | 2 | 1.58 |
| 2025-05 | 2 | 1.66 |
| 2025-06 | 2 | 1.76 |
| 2025-07 | 0 | 1.66 |
| 2025-08 | 2 | 1.51 |
| 2025-09 | 1 | 1.48 |
| 2025-10 | 0 | 1.56 |
| 2025-11 | 0 | 1.74 |
| 2025-12 | 2 | 2.08 |
| 2026-01 | 0 | 1.81 |
| 2026-02 | 2 | 1.79 |
| 2026-03 | 2 | 1.66 |
| 2026-04 | 0 | 1.69 |
| 2026-05 | 1 | 1.65 |
| 2026-06 | 1 | 1.68 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K062250 — cited as predicate by K170452, K170748, K170893, K172054, K183077, K190286, K192448, K193394, K193560, K210167, K212569, K212737, K220452, K230315, K231112, K233408, K241143, K242813, K250338, K260802
K081620 — cited as predicate by K212737
K120174 — cited as predicate by K170893, K172054, K183077, K190286, K192448, K192855, K193560, K203694, K210167, K210207, K212569, K212737, K220452, K230315, K231112, K233408, K241143, K242813, K260802
K192855 — cites (transitively): K071379 (d1), K120174 (d1), K122698 (d1), K170748 (d1), K052906 (d2), K060704 (d2), K062250 (d2), K101996 (d2), K133834 (d2) — cited as predicate by K203694, K211553
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — DEPUY (IRELAND)
- NAI 2024-07-04 DEPUY (IRELAND) · 0 citations
- NAI 2015-01-08 DEPUY (IRELAND) · 0 citations
- VAI 2012-01-26 DEPUY (IRELAND) · 1 citations
- NAI 2011-02-03 DEPUY (IRELAND) · 0 citations