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ACCURIS

Model 71236509 · Smith & Nephew, Inc. · DI 03596010477057

HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3520

UDILibrary device dossier · generated 2026-09-07 · 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.

13462019-01: 0 reports for this device; peer average 1.68/device2019-02: 0 reports for this device; peer average 1.71/device2019-03: 0 reports for this device; peer average 1.57/device2019-04: 0 reports for this device; peer average 1.9/device2019-05: 0 reports for this device; peer average 1.77/device2019-06: 0 reports for this device; peer average 1.78/device2019-07: 0 reports for this device; peer average 1.44/device2019-08: 0 reports for this device; peer average 1.67/device2019-09: 0 reports for this device; peer average 1.79/device2019-10: 0 reports for this device; peer average 1.84/device2019-11: 0 reports for this device; peer average 1.25/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 1.33/device2020-02: 0 reports for this device; peer average 2.07/device2020-03: 0 reports for this device; peer average 2.73/device2020-04: 0 reports for this device; peer average 1.43/device2020-05: 0 reports for this device; peer average 1.22/device2020-06: 0 reports for this device; peer average 2.65/device2020-07: 0 reports for this device; peer average 2.32/device2020-08: 0 reports for this device; peer average 2.84/device2020-09: 0 reports for this device; peer average 1.82/device2020-10: 0 reports for this device; peer average 1.79/device2020-11: 0 reports for this device; peer average 2.82/device2020-12: 0 reports for this device; peer average 2.14/device2021-01: 0 reports for this device; peer average 2.13/device2021-02: 0 reports for this device; peer average 2.44/device2021-03: 0 reports for this device; peer average 2.1/device2021-04: 0 reports for this device; peer average 2.7/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2.92/device2021-07: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 2.19/device2021-09: 0 reports for this device; peer average 2.68/device2021-10: 0 reports for this device; peer average 3.73/device2021-11: 0 reports for this device; peer average 2.31/device2021-12: 0 reports for this device; peer average 2.88/device2022-01: 0 reports for this device; peer average 1.82/device2022-02: 0 reports for this device; peer average 2.21/device2022-03: 0 reports for this device; peer average 2.9/device2022-04: 0 reports for this device; peer average 2.47/device2022-05: 0 reports for this device; peer average 2.4/device2022-06: 0 reports for this device; peer average 2.3/device2022-07: 0 reports for this device; peer average 2.82/device2022-08: 0 reports for this device; peer average 2.06/device2022-09: 0 reports for this device; peer average 5.83/device2022-10: 0 reports for this device; peer average 2.15/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 2.67/device2023-03: 0 reports for this device; peer average 2.44/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 2.59/device2023-06: 0 reports for this device; peer average 3.19/device2023-07: 0 reports for this device; peer average 2.22/device2023-08: 0 reports for this device; peer average 2.39/device2023-09: 0 reports for this device; peer average 1.5/device2023-10: 0 reports for this device; peer average 1.84/device2023-11: 0 reports for this device; peer average 2.12/device2023-12: 0 reports for this device; peer average 1.62/device2024-01: 0 reports for this device; peer average 2.67/device2024-02: 0 reports for this device; peer average 1.64/device2024-03: 0 reports for this device; peer average 1.91/device2024-04: 0 reports for this device; peer average 2.06/device2024-05: 0 reports for this device; peer average 1.77/device2024-06: 0 reports for this device; peer average 1.63/device2024-07: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 1.43/device2024-09: 0 reports for this device; peer average 1.56/device2024-10: 0 reports for this device; peer average 1.84/device2024-11: 0 reports for this device; peer average 1.61/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 1.78/device2025-02: 0 reports for this device; peer average 1.62/device2025-03: 0 reports for this device; peer average 1.75/device2025-04: 0 reports for this device; peer average 1.58/device2025-05: 0 reports for this device; peer average 1.54/device2025-06: 0 reports for this device; peer average 1.71/device2025-07: 0 reports for this device; peer average 2.19/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1.67/device2025-10: 0 reports for this device; peer average 1.83/device2025-11: 0 reports for this device; peer average 1.73/device2025-12: 0 reports for this device; peer average 1.61/device2026-01: 0 reports for this device; peer average 1.89/device2026-02: 0 reports for this device; peer average 1.9/device2026-03: 0 reports for this device; peer average 2.28/device2026-04: 0 reports for this device; peer average 1.69/device2026-05: 0 reports for this device; peer average 2.13/device2026-06: 0 reports for this device; peer average 2.29/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.68
2019-0201.71
2019-0301.57
2019-0401.9
2019-0501.77
2019-0601.78
2019-0701.44
2019-0801.67
2019-0901.79
2019-1001.84
2019-1101.25
2019-1202
2020-0101.33
2020-0202.07
2020-0302.73
2020-0401.43
2020-0501.22
2020-0602.65
2020-0702.32
2020-0802.84
2020-0901.82
2020-1001.79
2020-1102.82
2020-1202.14
2021-0102.13
2021-0202.44
2021-0302.1
2021-0402.7
2021-0502
2021-0602.92
2021-0703
2021-0802.19
2021-0902.68
2021-1003.73
2021-1102.31
2021-1202.88
2022-0101.82
2022-0202.21
2022-0302.9
2022-0402.47
2022-0502.4
2022-0602.3
2022-0702.82
2022-0802.06
2022-0905.83
2022-1002.15
2022-1102
2022-1202
2023-0102.5
2023-0202.67
2023-0302.44
2023-0402
2023-0502.59
2023-0603.19
2023-0702.22
2023-0802.39
2023-0901.5
2023-1001.84
2023-1102.12
2023-1201.62
2024-0102.67
2024-0201.64
2024-0301.91
2024-0402.06
2024-0501.77
2024-0601.63
2024-0702
2024-0801.43
2024-0901.56
2024-1001.84
2024-1101.61
2024-1202
2025-0101.78
2025-0201.62
2025-0301.75
2025-0401.58
2025-0501.54
2025-0601.71
2025-0702.19
2025-0802
2025-0901.67
2025-1001.83
2025-1101.73
2025-1201.61
2026-0101.89
2026-0201.9
2026-0302.28
2026-0401.69
2026-0502.13
2026-0602.29
This device (reports/month)Average device in HSX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K113038 — cites (transitively): K030301 (d1), K051086 (d1), K061011 (d1), K061569 (d1), K061779 (d1), K073175 (d1), K102069 (d1), K912735 (d2)

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

Manufacturer compliance record — Smith & Nephew, Inc.

  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2014-06-11 Smith & Nephew, Inc.
  • Warning Letter 2010-09-16 Ascension Orthopedics, Inc
  • NAI 2025-01-27 Integrity Orthopaedics Inc · 0 citations
  • NAI 2023-05-03 CARTIHEAL, LTD · 0 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • VAI 2020-02-06 Blue Belt Technologies, Inc · 6 citations
  • NAI 2019-10-25 Tusker Medical, Inc. · 0 citations
  • VAI 2019-10-08 Tusker Medical, Inc. · 3 citations
  • NAI 2018-03-30 Ascension Orthopedics, Inc · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-01-30 Smith & Nephew · 0 citations
  • NAI 2017-08-21 Smith & Nephew, Inc. Advanced Surgical Devices Division · 0 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations