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DELTA XTEND

Model 1307-38-709 · DEPUY ORTHOPAEDICS, INC. · DI 10603295027508

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 (3)

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: 3

12232019-01: 0 reports for this device; peer average 1.71/device2019-02: 0 reports for this device; peer average 1.54/device2019-03: 0 reports for this device; peer average 1.66/device2019-04: 0 reports for this device; peer average 1.53/device2019-05: 0 reports for this device; peer average 1.78/device2019-06: 0 reports for this device; peer average 1.84/device2019-07: 0 reports for this device; peer average 1.38/device2019-08: 0 reports for this device; peer average 1.99/device2019-09: 0 reports for this device; peer average 1.51/device2019-10: 0 reports for this device; peer average 1.76/device2019-11: 0 reports for this device; peer average 1.63/device2019-12: 0 reports for this device; peer average 1.72/device2020-01: 0 reports for this device; peer average 1.95/device2020-02: 0 reports for this device; peer average 2.16/device2020-03: 0 reports for this device; peer average 1.64/device2020-04: 0 reports for this device; peer average 1.7/device2020-05: 0 reports for this device; peer average 1.51/device2020-06: 0 reports for this device; peer average 1.83/device2020-07: 0 reports for this device; peer average 1.94/device2020-08: 0 reports for this device; peer average 1.73/device2020-09: 0 reports for this device; peer average 1.95/device2020-10: 0 reports for this device; peer average 2/device2020-11: 0 reports for this device; peer average 1.83/device2020-12: 0 reports for this device; peer average 1.79/device2021-01: 0 reports for this device; peer average 1.93/device2021-02: 0 reports for this device; peer average 1.92/device2021-03: 0 reports for this device; peer average 2.02/device2021-04: 0 reports for this device; peer average 1.87/device2021-05: 0 reports for this device; peer average 1.78/device2021-06: 0 reports for this device; peer average 1.58/device2021-07: 0 reports for this device; peer average 1.92/device2021-08: 0 reports for this device; peer average 2.1/device2021-09: 0 reports for this device; peer average 1.74/device2021-10: 0 reports for this device; peer average 1.82/device2021-11: 0 reports for this device; peer average 1.99/device2021-12: 0 reports for this device; peer average 1.92/device2022-01: 0 reports for this device; peer average 2.14/device2022-02: 0 reports for this device; peer average 2.1/device2022-03: 0 reports for this device; peer average 1.77/device2022-04: 0 reports for this device; peer average 2.07/device2022-05: 0 reports for this device; peer average 1.93/device2022-06: 0 reports for this device; peer average 2.03/device2022-07: 0 reports for this device; peer average 2.15/device2022-08: 0 reports for this device; peer average 1.98/device2022-09: 0 reports for this device; peer average 1.88/device2022-10: 0 reports for this device; peer average 1.87/device2022-11: 0 reports for this device; peer average 1.93/device2022-12: 0 reports for this device; peer average 1.81/device2023-01: 0 reports for this device; peer average 1.75/device2023-02: 0 reports for this device; peer average 1.83/device2023-03: 3 reports for this device; peer average 1.96/device2023-04: 0 reports for this device; peer average 1.94/device2023-05: 0 reports for this device; peer average 2.01/device2023-06: 0 reports for this device; peer average 2.21/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.61/device2023-09: 0 reports for this device; peer average 1.44/device2023-10: 0 reports for this device; peer average 1.57/device2023-11: 0 reports for this device; peer average 1.56/device2023-12: 0 reports for this device; peer average 1.39/device2024-01: 0 reports for this device; peer average 1.81/device2024-02: 0 reports for this device; peer average 1.64/device2024-03: 0 reports for this device; peer average 1.59/device2024-04: 0 reports for this device; peer average 1.74/device2024-05: 0 reports for this device; peer average 1.59/device2024-06: 0 reports for this device; peer average 1.88/device2024-07: 0 reports for this device; peer average 1.5/device2024-08: 0 reports for this device; peer average 1.68/device2024-09: 0 reports for this device; peer average 1.61/device2024-10: 0 reports for this device; peer average 1.59/device2024-11: 0 reports for this device; peer average 1.51/device2024-12: 0 reports for this device; peer average 1.55/device2025-01: 0 reports for this device; peer average 1.67/device2025-02: 0 reports for this device; peer average 1.52/device2025-03: 0 reports for this device; peer average 1.78/device2025-04: 0 reports for this device; peer average 1.58/device2025-05: 0 reports for this device; peer average 1.66/device2025-06: 0 reports for this device; peer average 1.76/device2025-07: 0 reports for this device; peer average 1.66/device2025-08: 0 reports for this device; peer average 1.51/device2025-09: 0 reports for this device; peer average 1.48/device2025-10: 0 reports for this device; peer average 1.56/device2025-11: 0 reports for this device; peer average 1.74/device2025-12: 0 reports for this device; peer average 2.08/device2026-01: 0 reports for this device; peer average 1.81/device2026-02: 0 reports for this device; peer average 1.79/device2026-03: 0 reports for this device; peer average 1.66/device2026-04: 0 reports for this device; peer average 1.69/device2026-05: 0 reports for this device; peer average 1.65/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)
2019-0101.71
2019-0201.54
2019-0301.66
2019-0401.53
2019-0501.78
2019-0601.84
2019-0701.38
2019-0801.99
2019-0901.51
2019-1001.76
2019-1101.63
2019-1201.72
2020-0101.95
2020-0202.16
2020-0301.64
2020-0401.7
2020-0501.51
2020-0601.83
2020-0701.94
2020-0801.73
2020-0901.95
2020-1002
2020-1101.83
2020-1201.79
2021-0101.93
2021-0201.92
2021-0302.02
2021-0401.87
2021-0501.78
2021-0601.58
2021-0701.92
2021-0802.1
2021-0901.74
2021-1001.82
2021-1101.99
2021-1201.92
2022-0102.14
2022-0202.1
2022-0301.77
2022-0402.07
2022-0501.93
2022-0602.03
2022-0702.15
2022-0801.98
2022-0901.88
2022-1001.87
2022-1101.93
2022-1201.81
2023-0101.75
2023-0201.83
2023-0331.96
2023-0401.94
2023-0502.01
2023-0602.21
2023-0702
2023-0801.61
2023-0901.44
2023-1001.57
2023-1101.56
2023-1201.39
2024-0101.81
2024-0201.64
2024-0301.59
2024-0401.74
2024-0501.59
2024-0601.88
2024-0701.5
2024-0801.68
2024-0901.61
2024-1001.59
2024-1101.51
2024-1201.55
2025-0101.67
2025-0201.52
2025-0301.78
2025-0401.58
2025-0501.66
2025-0601.76
2025-0701.66
2025-0801.51
2025-0901.48
2025-1001.56
2025-1101.74
2025-1202.08
2026-0101.81
2026-0201.79
2026-0301.66
2026-0401.69
2026-0501.65
2026-0601.68
This device (reports/month)Average device in HSD, KWS (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K091751 — cited as predicate by K142139

K120174 — cited as predicate by K170893, K172054, K183077, K190286, K192448, K192855, K193560, K203694, K210167, K210207, K212569, K212737, K220452, K230315, K231112, K233408, K241143, K242813, K260802

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

Manufacturer compliance record — DEPUY ORTHOPAEDICS, INC.

  • Warning Letter 2011-12-08 DePuy Orthopaedics, Inc.
  • Warning Letter 2010-08-19 DePuy Orthopaedics, Inc.
  • NAI 2024-03-28 DePuy Orthopaedics, Inc. · 0 citations
  • NAI 2022-05-12 DePuy Orthopaedics, Inc. · 0 citations
  • NAI 2019-11-08 DePuy Orthopaedics, Inc. · 0 citations
  • VAI 2017-09-01 DePuy Orthopaedics, Inc. · 2 citations
  • VAI 2015-10-01 DePuy Orthopaedics, Inc. · 2 citations
  • NAI 2015-09-24 DePuy Orthopaedics, Inc. · 0 citations
  • VAI 2012-11-26 DePuy Orthopaedics, Inc. · 6 citations
  • NAI 2011-08-16 DePuy Orthopaedics, Inc. · 0 citations
  • OAI 2011-06-07 DePuy Orthopaedics, Inc. · 6 citations