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ADVANCE®

Model K0051005 · Microport Orthopedics Inc. · DI M684K00510051

HWB — Extractor · Class I · 21 CFR 888.4540

UDILibrary device dossier · generated 2026-09-11 · 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.

12332019-01: 0 reports for this device; peer average 2.07/device2019-02: 0 reports for this device; peer average 1.27/device2019-03: 0 reports for this device; peer average 1.78/device2019-04: 0 reports for this device; peer average 2.83/device2019-05: 0 reports for this device; peer average 1.8/device2019-06: 0 reports for this device; peer average 1.67/device2019-07: 0 reports for this device; peer average 1.75/device2019-08: 0 reports for this device; peer average 2.09/device2019-09: 0 reports for this device; peer average 1.5/device2019-10: 0 reports for this device; peer average 1.88/device2019-11: 0 reports for this device; peer average 1.5/device2019-12: 0 reports for this device; peer average 1.68/device2020-01: 0 reports for this device; peer average 2.6/device2020-02: 0 reports for this device; peer average 1.78/device2020-03: 0 reports for this device; peer average 2.5/device2020-04: 0 reports for this device; peer average 1.55/device2020-05: 0 reports for this device; peer average 1.27/device2020-06: 0 reports for this device; peer average 1.5/device2020-07: 0 reports for this device; peer average 2.1/device2020-08: 0 reports for this device; peer average 2.14/device2020-09: 0 reports for this device; peer average 1.39/device2020-10: 0 reports for this device; peer average 3.38/device2020-11: 0 reports for this device; peer average 1.91/device2020-12: 0 reports for this device; peer average 2.38/device2021-01: 0 reports for this device; peer average 2.93/device2021-02: 0 reports for this device; peer average 1.63/device2021-03: 0 reports for this device; peer average 2.64/device2021-04: 0 reports for this device; peer average 2.11/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 1.93/device2021-07: 0 reports for this device; peer average 2.83/device2021-08: 0 reports for this device; peer average 1.47/device2021-09: 0 reports for this device; peer average 2.2/device2021-10: 0 reports for this device; peer average 1.71/device2021-11: 0 reports for this device; peer average 2.36/device2021-12: 0 reports for this device; peer average 1.7/device2022-01: 0 reports for this device; peer average 2.89/device2022-02: 0 reports for this device; peer average 1.76/device2022-03: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 2.7/device2022-05: 0 reports for this device; peer average 2.08/device2022-06: 0 reports for this device; peer average 1.71/device2022-07: 0 reports for this device; peer average 1.81/device2022-08: 0 reports for this device; peer average 2.64/device2022-09: 0 reports for this device; peer average 2.44/device2022-10: 0 reports for this device; peer average 1.5/device2022-11: 0 reports for this device; peer average 2.53/device2022-12: 0 reports for this device; peer average 1.87/device2023-01: 0 reports for this device; peer average 2.88/device2023-02: 0 reports for this device; peer average 1.77/device2023-03: 0 reports for this device; peer average 1.82/device2023-04: 0 reports for this device; peer average 2.64/device2023-05: 0 reports for this device; peer average 2.08/device2023-06: 0 reports for this device; peer average 1.95/device2023-07: 0 reports for this device; peer average 2.13/device2023-08: 0 reports for this device; peer average 1.78/device2023-09: 0 reports for this device; peer average 1.33/device2023-10: 0 reports for this device; peer average 2.56/device2023-11: 0 reports for this device; peer average 2.4/device2023-12: 0 reports for this device; peer average 2.1/device2024-01: 0 reports for this device; peer average 1.69/device2024-02: 0 reports for this device; peer average 1.92/device2024-03: 0 reports for this device; peer average 1.93/device2024-04: 0 reports for this device; peer average 1.5/device2024-05: 0 reports for this device; peer average 1.75/device2024-06: 0 reports for this device; peer average 1.86/device2024-07: 0 reports for this device; peer average 1.56/device2024-08: 0 reports for this device; peer average 1.3/device2024-09: 0 reports for this device; peer average 1.94/device2024-10: 0 reports for this device; peer average 2.29/device2024-11: 0 reports for this device; peer average 2.18/device2024-12: 0 reports for this device; peer average 1.56/device2025-01: 0 reports for this device; peer average 3.1/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 1.54/device2025-04: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 2.08/device2025-06: 0 reports for this device; peer average 1.75/device2025-07: 0 reports for this device; peer average 2.07/device2025-08: 0 reports for this device; peer average 1.3/device2025-09: 0 reports for this device; peer average 2.3/device2025-10: 0 reports for this device; peer average 2.27/device2025-11: 0 reports for this device; peer average 3.09/device2025-12: 0 reports for this device; peer average 2.17/device2026-01: 0 reports for this device; peer average 1.85/device2026-02: 0 reports for this device; peer average 2.36/device2026-03: 0 reports for this device; peer average 2.64/device2026-04: 0 reports for this device; peer average 2.22/device2026-05: 0 reports for this device; peer average 1.67/device2026-06: 0 reports for this device; peer average 1.4/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.07
2019-0201.27
2019-0301.78
2019-0402.83
2019-0501.8
2019-0601.67
2019-0701.75
2019-0802.09
2019-0901.5
2019-1001.88
2019-1101.5
2019-1201.68
2020-0102.6
2020-0201.78
2020-0302.5
2020-0401.55
2020-0501.27
2020-0601.5
2020-0702.1
2020-0802.14
2020-0901.39
2020-1003.38
2020-1101.91
2020-1202.38
2021-0102.93
2021-0201.63
2021-0302.64
2021-0402.11
2021-0502
2021-0601.93
2021-0702.83
2021-0801.47
2021-0902.2
2021-1001.71
2021-1102.36
2021-1201.7
2022-0102.89
2022-0201.76
2022-0302
2022-0402.7
2022-0502.08
2022-0601.71
2022-0701.81
2022-0802.64
2022-0902.44
2022-1001.5
2022-1102.53
2022-1201.87
2023-0102.88
2023-0201.77
2023-0301.82
2023-0402.64
2023-0502.08
2023-0601.95
2023-0702.13
2023-0801.78
2023-0901.33
2023-1002.56
2023-1102.4
2023-1202.1
2024-0101.69
2024-0201.92
2024-0301.93
2024-0401.5
2024-0501.75
2024-0601.86
2024-0701.56
2024-0801.3
2024-0901.94
2024-1002.29
2024-1102.18
2024-1201.56
2025-0103.1
2025-0202
2025-0301.54
2025-0402
2025-0502.08
2025-0601.75
2025-0702.07
2025-0801.3
2025-0902.3
2025-1002.27
2025-1103.09
2025-1202.17
2026-0101.85
2026-0202.36
2026-0302.64
2026-0402.22
2026-0501.67
2026-0601.4
This device (reports/month)Average device in HWB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Microport Orthopedics Inc.

  • Warning Letter 2015-06-17 MicroPort Orthopedics Inc.
  • Warning Letter 2015-06-17 MicroPort Orthopedics Inc.
  • NAI 2023-02-08 MicroPort Orthopedics Inc. · 0 citations
  • NAI 2023-02-08 MicroPort Orthopedics Inc. · 0 citations
  • VAI 2018-06-29 MicroPort Orthopedics Inc. · 2 citations
  • VAI 2018-06-29 MicroPort Orthopedics Inc. · 2 citations
  • VAI 2015-08-19 MicroPort Orthopedics Inc. · 5 citations
  • VAI 2015-08-19 MicroPort Orthopedics Inc. · 5 citations