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INHANCE

Model 5507-04-100 · DEPUY (IRELAND) · DI 10603295546931

MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3670

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

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

UDILibrary device dossier · generated 2026-09-13 · 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 1.97/device2019-02: 0 reports for this device; peer average 2.17/device2019-03: 0 reports for this device; peer average 1.83/device2019-04: 0 reports for this device; peer average 2.24/device2019-05: 0 reports for this device; peer average 2.5/device2019-06: 0 reports for this device; peer average 1.83/device2019-07: 0 reports for this device; peer average 2.12/device2019-08: 0 reports for this device; peer average 2.45/device2019-09: 0 reports for this device; peer average 1.94/device2019-10: 0 reports for this device; peer average 1.96/device2019-11: 0 reports for this device; peer average 1.64/device2019-12: 0 reports for this device; peer average 1.77/device2020-01: 0 reports for this device; peer average 1.88/device2020-02: 0 reports for this device; peer average 1.86/device2020-03: 0 reports for this device; peer average 2.51/device2020-04: 0 reports for this device; peer average 1.67/device2020-05: 0 reports for this device; peer average 1.84/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2.72/device2020-08: 0 reports for this device; peer average 1.85/device2020-09: 0 reports for this device; peer average 1.99/device2020-10: 0 reports for this device; peer average 2.24/device2020-11: 0 reports for this device; peer average 1.9/device2020-12: 0 reports for this device; peer average 1.84/device2021-01: 0 reports for this device; peer average 2.32/device2021-02: 0 reports for this device; peer average 2.04/device2021-03: 0 reports for this device; peer average 2.16/device2021-04: 0 reports for this device; peer average 2.28/device2021-05: 0 reports for this device; peer average 2.04/device2021-06: 0 reports for this device; peer average 2.19/device2021-07: 0 reports for this device; peer average 2.15/device2021-08: 0 reports for this device; peer average 2.39/device2021-09: 0 reports for this device; peer average 2.06/device2021-10: 0 reports for this device; peer average 2.68/device2021-11: 0 reports for this device; peer average 2.21/device2021-12: 0 reports for this device; peer average 3.01/device2022-01: 0 reports for this device; peer average 3.04/device2022-02: 0 reports for this device; peer average 2.59/device2022-03: 0 reports for this device; peer average 2.87/device2022-04: 0 reports for this device; peer average 2.75/device2022-05: 0 reports for this device; peer average 2.19/device2022-06: 0 reports for this device; peer average 2.32/device2022-07: 0 reports for this device; peer average 2.19/device2022-08: 0 reports for this device; peer average 2.33/device2022-09: 0 reports for this device; peer average 2.1/device2022-10: 0 reports for this device; peer average 2.06/device2022-11: 0 reports for this device; peer average 2.21/device2022-12: 0 reports for this device; peer average 2.14/device2023-01: 0 reports for this device; peer average 1.86/device2023-02: 0 reports for this device; peer average 1.94/device2023-03: 0 reports for this device; peer average 1.94/device2023-04: 0 reports for this device; peer average 2.41/device2023-05: 0 reports for this device; peer average 2.02/device2023-06: 0 reports for this device; peer average 2.15/device2023-07: 0 reports for this device; peer average 1.96/device2023-08: 0 reports for this device; peer average 1.67/device2023-09: 0 reports for this device; peer average 1.56/device2023-10: 0 reports for this device; peer average 1.61/device2023-11: 0 reports for this device; peer average 1.76/device2023-12: 0 reports for this device; peer average 1.43/device2024-01: 0 reports for this device; peer average 1.61/device2024-02: 0 reports for this device; peer average 1.98/device2024-03: 0 reports for this device; peer average 1.63/device2024-04: 0 reports for this device; peer average 1.83/device2024-05: 0 reports for this device; peer average 1.63/device2024-06: 0 reports for this device; peer average 1.75/device2024-07: 0 reports for this device; peer average 1.63/device2024-08: 0 reports for this device; peer average 1.65/device2024-09: 0 reports for this device; peer average 1.59/device2024-10: 0 reports for this device; peer average 1.7/device2024-11: 0 reports for this device; peer average 1.54/device2024-12: 0 reports for this device; peer average 1.53/device2025-01: 0 reports for this device; peer average 1.68/device2025-02: 0 reports for this device; peer average 1.61/device2025-03: 0 reports for this device; peer average 1.87/device2025-04: 0 reports for this device; peer average 1.66/device2025-05: 0 reports for this device; peer average 1.84/device2025-06: 0 reports for this device; peer average 1.96/device2025-07: 0 reports for this device; peer average 1.76/device2025-08: 0 reports for this device; peer average 1.63/device2025-09: 0 reports for this device; peer average 1.41/device2025-10: 0 reports for this device; peer average 1.59/device2025-11: 0 reports for this device; peer average 1.7/device2025-12: 0 reports for this device; peer average 2.29/device2026-01: 0 reports for this device; peer average 1.96/device2026-02: 0 reports for this device; peer average 1.71/device2026-03: 0 reports for this device; peer average 1.73/device2026-04: 0 reports for this device; peer average 1.73/device2026-05: 0 reports for this device; peer average 1.68/device2026-06: 0 reports for this device; peer average 1.75/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.97
2019-0202.17
2019-0301.83
2019-0402.24
2019-0502.5
2019-0601.83
2019-0702.12
2019-0802.45
2019-0901.94
2019-1001.96
2019-1101.64
2019-1201.77
2020-0101.88
2020-0201.86
2020-0302.51
2020-0401.67
2020-0501.84
2020-0602
2020-0702.72
2020-0801.85
2020-0901.99
2020-1002.24
2020-1101.9
2020-1201.84
2021-0102.32
2021-0202.04
2021-0302.16
2021-0402.28
2021-0502.04
2021-0602.19
2021-0702.15
2021-0802.39
2021-0902.06
2021-1002.68
2021-1102.21
2021-1203.01
2022-0103.04
2022-0202.59
2022-0302.87
2022-0402.75
2022-0502.19
2022-0602.32
2022-0702.19
2022-0802.33
2022-0902.1
2022-1002.06
2022-1102.21
2022-1202.14
2023-0101.86
2023-0201.94
2023-0301.94
2023-0402.41
2023-0502.02
2023-0602.15
2023-0701.96
2023-0801.67
2023-0901.56
2023-1001.61
2023-1101.76
2023-1201.43
2024-0101.61
2024-0201.98
2024-0301.63
2024-0401.83
2024-0501.63
2024-0601.75
2024-0701.63
2024-0801.65
2024-0901.59
2024-1001.7
2024-1101.54
2024-1201.53
2025-0101.68
2025-0201.61
2025-0301.87
2025-0401.66
2025-0501.84
2025-0601.96
2025-0701.76
2025-0801.63
2025-0901.41
2025-1001.59
2025-1101.7
2025-1202.29
2026-0101.96
2026-0201.71
2026-0301.73
2026-0401.73
2026-0501.68
2026-0601.75
This device (reports/month)Average device in MBF, PAO, PHX (reports/device/month)

Regulatory clearances

  • K221467 SESE 2022-08-31 (k number procode)

Predicate lineage

K221467 — cites (transitively): K183077 (d1), K202611 (d1), K202716 (d1), K212737 (d1), K030941 (d2), K061439 (d2), K062250 (d2), K081059 (d2), K120174 (d2), K140478 (d2), K151293 (d2), K141990 (d2), K162455 (d2), K172351 (d2), K173900 (d2), K190290 (d2), K193372 (d2), K052472 (d2), K060692 (d2), K060694 (d2), K060716 (d2), K091196 (d2), K111596 (d2), K121183 (d2), K122698 (d2), K162024 (d2), K905786 (d2), K052906 (d2), K071379 (d2), K081620 (d2), K130048 (d2), K130050 (d2), K161742 (d2), K181611 (d2), K193373 (d2), K203108 (d2), K102670 (d3), K982981 (d3), K080402 (d3), K082120 (d3), K100741 (d3), K103208 (d3), K111735 (d3), K140904 (d3), K950594 (d3), K950651 (d3), K041066 (d3), K050316 (d3), K051075 (d3), K092873 (d3), K100142 (d3), K112069 (d3), K132285 (d3), K140082 (d3), K110708 (d3), K113413 (d3), K123982 (d3), K150488 (d3), K111061 (d3), K141006 (d3), K133349 (d3), K142863 (d3), K013991 (d3), K080642 (d3), K113069 (d3), K131353 (d3), K133378 (d3), K113121 (d3), K120121 (d3), K132239 (d3), K152754 (d3), K083439 (d3), K143552 (d3), K171858 (d3), K173388 (d3), K182516 (d3), K183194 (d3), K193226 (d3), K071147 (d4), K053274 (d4), K130129 (d4), K103007 (d4), K123814 (d4), K130759 (d4), K140071 (d4), K042021 (d4), K102975 (d4), K131298 (d4), K140063 (d4), K153595 (d4), K071032 (d4), K070479 (d5), K060988 (d5), K073331 (d5), K060874 (d5), K111097 (d5), K992525 (d5), K023096 (d5), K093430 (d5), K994392 (d5), K143393 (d5), K053340 (d6), K100391 (d6), K123486 (d6), K132624 (d6), K042871 (d7), K052888 (d7), K072160 (d7), K031729 (d7), K040267 (d7), K042883 (d7), K042993 (d7), K051146 (d7), K051380 (d7), K051977 (d7), K053514 (d7), K061521 (d7), K072221 (d7), K072575 (d7), K123166 (d7), K050539 (d8), K063423 (d8), K974556 (d8) — cited as predicate by K241143, K242813, K260802

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