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ADVANCE®

Model K0027302 · Microport Orthopedics Inc. · DI M684K00273021

HTQ — Broach · 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.

25792019-01: 0 reports for this device; peer average 2.16/device2019-02: 0 reports for this device; peer average 1.22/device2019-03: 0 reports for this device; peer average 1.65/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1.94/device2019-06: 0 reports for this device; peer average 1.5/device2019-07: 0 reports for this device; peer average 1.83/device2019-08: 0 reports for this device; peer average 1.5/device2019-09: 0 reports for this device; peer average 2.24/device2019-10: 0 reports for this device; peer average 4.32/device2019-11: 0 reports for this device; peer average 2.15/device2019-12: 0 reports for this device; peer average 2.25/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1.89/device2020-03: 0 reports for this device; peer average 2.33/device2020-04: 0 reports for this device; peer average 2.29/device2020-05: 0 reports for this device; peer average 1.46/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1.81/device2020-08: 0 reports for this device; peer average 2.33/device2020-09: 0 reports for this device; peer average 1.73/device2020-10: 0 reports for this device; peer average 1.91/device2020-11: 0 reports for this device; peer average 1.57/device2020-12: 0 reports for this device; peer average 2.19/device2021-01: 0 reports for this device; peer average 1.53/device2021-02: 0 reports for this device; peer average 1.64/device2021-03: 0 reports for this device; peer average 1.83/device2021-04: 0 reports for this device; peer average 3.46/device2021-05: 0 reports for this device; peer average 1.43/device2021-06: 0 reports for this device; peer average 1.5/device2021-07: 0 reports for this device; peer average 1.56/device2021-08: 0 reports for this device; peer average 3.23/device2021-09: 0 reports for this device; peer average 2.06/device2021-10: 0 reports for this device; peer average 1.85/device2021-11: 0 reports for this device; peer average 1.86/device2021-12: 0 reports for this device; peer average 1.7/device2022-01: 0 reports for this device; peer average 1.87/device2022-02: 0 reports for this device; peer average 2.23/device2022-03: 0 reports for this device; peer average 2.46/device2022-04: 0 reports for this device; peer average 1.56/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 1.88/device2022-07: 0 reports for this device; peer average 3.71/device2022-08: 0 reports for this device; peer average 1.87/device2022-09: 0 reports for this device; peer average 1.7/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 2.14/device2022-12: 0 reports for this device; peer average 2.86/device2023-01: 0 reports for this device; peer average 2.81/device2023-02: 0 reports for this device; peer average 2.07/device2023-03: 0 reports for this device; peer average 1.62/device2023-04: 0 reports for this device; peer average 2.11/device2023-05: 0 reports for this device; peer average 1.48/device2023-06: 0 reports for this device; peer average 1.82/device2023-07: 0 reports for this device; peer average 2.13/device2023-08: 0 reports for this device; peer average 2.54/device2023-09: 0 reports for this device; peer average 1.92/device2023-10: 0 reports for this device; peer average 3.36/device2023-11: 0 reports for this device; peer average 2.05/device2023-12: 0 reports for this device; peer average 2.09/device2024-01: 0 reports for this device; peer average 2.33/device2024-02: 0 reports for this device; peer average 3.43/device2024-03: 0 reports for this device; peer average 1.69/device2024-04: 0 reports for this device; peer average 1.82/device2024-05: 0 reports for this device; peer average 1.7/device2024-06: 0 reports for this device; peer average 2.67/device2024-07: 0 reports for this device; peer average 1.33/device2024-08: 0 reports for this device; peer average 1.41/device2024-09: 0 reports for this device; peer average 1.5/device2024-10: 0 reports for this device; peer average 1.97/device2024-11: 0 reports for this device; peer average 2.17/device2024-12: 0 reports for this device; peer average 1.62/device2025-01: 0 reports for this device; peer average 1.82/device2025-02: 0 reports for this device; peer average 1.22/device2025-03: 0 reports for this device; peer average 1.42/device2025-04: 0 reports for this device; peer average 1.47/device2025-05: 0 reports for this device; peer average 3.38/device2025-06: 0 reports for this device; peer average 2.21/device2025-07: 0 reports for this device; peer average 2.23/device2025-08: 0 reports for this device; peer average 1.54/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 2.07/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1.4/device2026-01: 0 reports for this device; peer average 3.64/device2026-02: 0 reports for this device; peer average 1.22/device2026-03: 0 reports for this device; peer average 9.44/device2026-04: 0 reports for this device; peer average 1.36/device2026-05: 0 reports for this device; peer average 1.8/device2026-06: 0 reports for this device; peer average 1.36/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.16
2019-0201.22
2019-0301.65
2019-0402
2019-0501.94
2019-0601.5
2019-0701.83
2019-0801.5
2019-0902.24
2019-1004.32
2019-1102.15
2019-1202.25
2020-0102
2020-0201.89
2020-0302.33
2020-0402.29
2020-0501.46
2020-0602
2020-0701.81
2020-0802.33
2020-0901.73
2020-1001.91
2020-1101.57
2020-1202.19
2021-0101.53
2021-0201.64
2021-0301.83
2021-0403.46
2021-0501.43
2021-0601.5
2021-0701.56
2021-0803.23
2021-0902.06
2021-1001.85
2021-1101.86
2021-1201.7
2022-0101.87
2022-0202.23
2022-0302.46
2022-0401.56
2022-0502
2022-0601.88
2022-0703.71
2022-0801.87
2022-0901.7
2022-1002
2022-1102.14
2022-1202.86
2023-0102.81
2023-0202.07
2023-0301.62
2023-0402.11
2023-0501.48
2023-0601.82
2023-0702.13
2023-0802.54
2023-0901.92
2023-1003.36
2023-1102.05
2023-1202.09
2024-0102.33
2024-0203.43
2024-0301.69
2024-0401.82
2024-0501.7
2024-0602.67
2024-0701.33
2024-0801.41
2024-0901.5
2024-1001.97
2024-1102.17
2024-1201.62
2025-0101.82
2025-0201.22
2025-0301.42
2025-0401.47
2025-0503.38
2025-0602.21
2025-0702.23
2025-0801.54
2025-0901
2025-1002.07
2025-1101
2025-1201.4
2026-0103.64
2026-0201.22
2026-0309.44
2026-0401.36
2026-0501.8
2026-0601.36
This device (reports/month)Average device in HTQ (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