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SIGMA

Model 1024-11-311 · DEPUY (IRELAND) · DI 10603295001942

HRY — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3530

KRR — Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3540

NPJ — Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560

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 (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.

23562019-01: 0 reports for this device; peer average 1.78/device2019-02: 0 reports for this device; peer average 1.74/device2019-03: 0 reports for this device; peer average 1.44/device2019-04: 0 reports for this device; peer average 1.52/device2019-05: 0 reports for this device; peer average 1.6/device2019-06: 0 reports for this device; peer average 1.89/device2019-07: 0 reports for this device; peer average 1.52/device2019-08: 0 reports for this device; peer average 1.47/device2019-09: 0 reports for this device; peer average 1.4/device2019-10: 0 reports for this device; peer average 1.58/device2019-11: 0 reports for this device; peer average 1.28/device2019-12: 0 reports for this device; peer average 2.17/device2020-01: 0 reports for this device; peer average 1.53/device2020-02: 0 reports for this device; peer average 1.82/device2020-03: 0 reports for this device; peer average 2.53/device2020-04: 0 reports for this device; peer average 1.79/device2020-05: 0 reports for this device; peer average 1.41/device2020-06: 0 reports for this device; peer average 3.38/device2020-07: 0 reports for this device; peer average 4.26/device2020-08: 0 reports for this device; peer average 3.87/device2020-09: 0 reports for this device; peer average 3.49/device2020-10: 0 reports for this device; peer average 4.37/device2020-11: 0 reports for this device; peer average 4.49/device2020-12: 0 reports for this device; peer average 6.4/device2021-01: 0 reports for this device; peer average 4.32/device2021-02: 0 reports for this device; peer average 5.04/device2021-03: 0 reports for this device; peer average 2.52/device2021-04: 0 reports for this device; peer average 2.33/device2021-05: 0 reports for this device; peer average 4.18/device2021-06: 0 reports for this device; peer average 4.22/device2021-07: 0 reports for this device; peer average 3.66/device2021-08: 0 reports for this device; peer average 3.93/device2021-09: 0 reports for this device; peer average 5.1/device2021-10: 0 reports for this device; peer average 3.29/device2021-11: 0 reports for this device; peer average 3.54/device2021-12: 0 reports for this device; peer average 3.66/device2022-01: 0 reports for this device; peer average 3.35/device2022-02: 0 reports for this device; peer average 4.62/device2022-03: 0 reports for this device; peer average 4.08/device2022-04: 0 reports for this device; peer average 4.06/device2022-05: 0 reports for this device; peer average 6.23/device2022-06: 0 reports for this device; peer average 3.43/device2022-07: 0 reports for this device; peer average 4.45/device2022-08: 0 reports for this device; peer average 3.38/device2022-09: 0 reports for this device; peer average 2.86/device2022-10: 0 reports for this device; peer average 3.88/device2022-11: 0 reports for this device; peer average 3.11/device2022-12: 0 reports for this device; peer average 4/device2023-01: 0 reports for this device; peer average 4.38/device2023-02: 0 reports for this device; peer average 3.29/device2023-03: 0 reports for this device; peer average 2.44/device2023-04: 0 reports for this device; peer average 4.04/device2023-05: 0 reports for this device; peer average 3.15/device2023-06: 0 reports for this device; peer average 3.64/device2023-07: 0 reports for this device; peer average 2.38/device2023-08: 0 reports for this device; peer average 2.18/device2023-09: 0 reports for this device; peer average 1.91/device2023-10: 0 reports for this device; peer average 2.15/device2023-11: 0 reports for this device; peer average 2.81/device2023-12: 0 reports for this device; peer average 2.03/device2024-01: 0 reports for this device; peer average 2.84/device2024-02: 0 reports for this device; peer average 2.33/device2024-03: 0 reports for this device; peer average 2.38/device2024-04: 0 reports for this device; peer average 2.79/device2024-05: 0 reports for this device; peer average 1.91/device2024-06: 0 reports for this device; peer average 2.33/device2024-07: 0 reports for this device; peer average 2.96/device2024-08: 0 reports for this device; peer average 2.46/device2024-09: 0 reports for this device; peer average 2.44/device2024-10: 0 reports for this device; peer average 2.2/device2024-11: 0 reports for this device; peer average 2.1/device2024-12: 0 reports for this device; peer average 2.82/device2025-01: 0 reports for this device; peer average 2.15/device2025-02: 0 reports for this device; peer average 2.03/device2025-03: 0 reports for this device; peer average 2.09/device2025-04: 0 reports for this device; peer average 2.26/device2025-05: 0 reports for this device; peer average 2.19/device2025-06: 0 reports for this device; peer average 1.91/device2025-07: 0 reports for this device; peer average 2.42/device2025-08: 0 reports for this device; peer average 1.77/device2025-09: 0 reports for this device; peer average 2.31/device2025-10: 0 reports for this device; peer average 2.5/device2025-11: 0 reports for this device; peer average 1.96/device2025-12: 0 reports for this device; peer average 2.5/device2026-01: 0 reports for this device; peer average 1.64/device2026-02: 0 reports for this device; peer average 2.1/device2026-03: 0 reports for this device; peer average 2.24/device2026-04: 0 reports for this device; peer average 1.94/device2026-05: 0 reports for this device; peer average 2.47/device2026-06: 0 reports for this device; peer average 1.97/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.78
2019-0201.74
2019-0301.44
2019-0401.52
2019-0501.6
2019-0601.89
2019-0701.52
2019-0801.47
2019-0901.4
2019-1001.58
2019-1101.28
2019-1202.17
2020-0101.53
2020-0201.82
2020-0302.53
2020-0401.79
2020-0501.41
2020-0603.38
2020-0704.26
2020-0803.87
2020-0903.49
2020-1004.37
2020-1104.49
2020-1206.4
2021-0104.32
2021-0205.04
2021-0302.52
2021-0402.33
2021-0504.18
2021-0604.22
2021-0703.66
2021-0803.93
2021-0905.1
2021-1003.29
2021-1103.54
2021-1203.66
2022-0103.35
2022-0204.62
2022-0304.08
2022-0404.06
2022-0506.23
2022-0603.43
2022-0704.45
2022-0803.38
2022-0902.86
2022-1003.88
2022-1103.11
2022-1204
2023-0104.38
2023-0203.29
2023-0302.44
2023-0404.04
2023-0503.15
2023-0603.64
2023-0702.38
2023-0802.18
2023-0901.91
2023-1002.15
2023-1102.81
2023-1202.03
2024-0102.84
2024-0202.33
2024-0302.38
2024-0402.79
2024-0501.91
2024-0602.33
2024-0702.96
2024-0802.46
2024-0902.44
2024-1002.2
2024-1102.1
2024-1202.82
2025-0102.15
2025-0202.03
2025-0302.09
2025-0402.26
2025-0502.19
2025-0601.91
2025-0702.42
2025-0801.77
2025-0902.31
2025-1002.5
2025-1101.96
2025-1202.5
2026-0101.64
2026-0202.1
2026-0302.24
2026-0401.94
2026-0502.47
2026-0601.97
This device (reports/month)Average device in HRY, KRR, NPJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K061648 — cited as predicate by K193549, K233980

K070849 — cited as predicate by K193549, K233980

K233980 — cites (transitively): K003182 (d1), K033959 (d1), K061648 (d1), K070267 (d1), K070849 (d1), K091453 (d1), K111433 (d1), K140881 (d1), K170806 (d1), K212746 (d1), K230295 (d1), K232303 (d1), K101433 (d2), K062654 (d2), K103756 (d2), K032151 (d2), K100391 (d2), K143393 (d2), K160700 (d2), K202194 (d2), K132624 (d2), K042871 (d3), K052888 (d3), K053340 (d3), K040166 (d3), K082500 (d3), K933785 (d3), K943462 (d3), K961685 (d3), K910500 (d3), K950010 (d3), K031729 (d3), K040267 (d3), K042883 (d3), K042993 (d3), K051146 (d3), K051380 (d3), K051977 (d3), K053514 (d3), K061521 (d3), K072221 (d3), K072575 (d3), K123166 (d3), K123486 (d3), K060515 (d3), K063633 (d3), K070095 (d3), K071417 (d3), K923807 (d3), K941769 (d3), K952830 (d3), K201347 (d3), K050539 (d4), K063423 (d4), K974556 (d4), K072160 (d4) — cited as predicate by K241000, K242665, K252887, K253197, K261458

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