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Unnamed device

Model 165-00-00 · Exactech, Inc. · DI 10885862661289

MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353

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.

11222019-01: 0 reports for this device; peer average 1.76/device2019-02: 0 reports for this device; peer average 1.61/device2019-03: 0 reports for this device; peer average 1.73/device2019-04: 0 reports for this device; peer average 1.93/device2019-05: 0 reports for this device; peer average 1.6/device2019-06: 0 reports for this device; peer average 1.3/device2019-07: 0 reports for this device; peer average 1.4/device2019-08: 0 reports for this device; peer average 1.61/device2019-09: 0 reports for this device; peer average 1.47/device2019-10: 0 reports for this device; peer average 1.57/device2019-11: 0 reports for this device; peer average 1.66/device2019-12: 0 reports for this device; peer average 1.55/device2020-01: 0 reports for this device; peer average 1.57/device2020-02: 0 reports for this device; peer average 1.55/device2020-03: 0 reports for this device; peer average 1.84/device2020-04: 0 reports for this device; peer average 1.52/device2020-05: 0 reports for this device; peer average 1.32/device2020-06: 0 reports for this device; peer average 1.45/device2020-07: 0 reports for this device; peer average 1.72/device2020-08: 0 reports for this device; peer average 1.48/device2020-09: 0 reports for this device; peer average 1.61/device2020-10: 0 reports for this device; peer average 1.61/device2020-11: 0 reports for this device; peer average 1.48/device2020-12: 0 reports for this device; peer average 1.56/device2021-01: 0 reports for this device; peer average 1.54/device2021-02: 0 reports for this device; peer average 1.43/device2021-03: 0 reports for this device; peer average 1.46/device2021-04: 0 reports for this device; peer average 1.53/device2021-05: 0 reports for this device; peer average 1.53/device2021-06: 0 reports for this device; peer average 1.6/device2021-07: 0 reports for this device; peer average 1.46/device2021-08: 0 reports for this device; peer average 1.39/device2021-09: 0 reports for this device; peer average 1.84/device2021-10: 0 reports for this device; peer average 1.51/device2021-11: 0 reports for this device; peer average 1.5/device2021-12: 0 reports for this device; peer average 1.4/device2022-01: 0 reports for this device; peer average 1.37/device2022-02: 0 reports for this device; peer average 1.47/device2022-03: 0 reports for this device; peer average 1.44/device2022-04: 0 reports for this device; peer average 1.41/device2022-05: 0 reports for this device; peer average 1.64/device2022-06: 0 reports for this device; peer average 1.55/device2022-07: 0 reports for this device; peer average 1.44/device2022-08: 0 reports for this device; peer average 1.65/device2022-09: 0 reports for this device; peer average 1.67/device2022-10: 0 reports for this device; peer average 1.59/device2022-11: 0 reports for this device; peer average 1.68/device2022-12: 0 reports for this device; peer average 1.37/device2023-01: 0 reports for this device; peer average 1.35/device2023-02: 0 reports for this device; peer average 1.48/device2023-03: 0 reports for this device; peer average 1.64/device2023-04: 0 reports for this device; peer average 1.79/device2023-05: 0 reports for this device; peer average 1.68/device2023-06: 0 reports for this device; peer average 1.9/device2023-07: 0 reports for this device; peer average 1.9/device2023-08: 0 reports for this device; peer average 1.71/device2023-09: 0 reports for this device; peer average 1.82/device2023-10: 0 reports for this device; peer average 1.42/device2023-11: 0 reports for this device; peer average 1.36/device2023-12: 0 reports for this device; peer average 1.4/device2024-01: 0 reports for this device; peer average 1.47/device2024-02: 0 reports for this device; peer average 1.67/device2024-03: 0 reports for this device; peer average 1.88/device2024-04: 0 reports for this device; peer average 1.63/device2024-05: 0 reports for this device; peer average 2.19/device2024-06: 0 reports for this device; peer average 1.9/device2024-07: 0 reports for this device; peer average 1.51/device2024-08: 0 reports for this device; peer average 1.99/device2024-09: 0 reports for this device; peer average 1.82/device2024-10: 0 reports for this device; peer average 1.66/device2024-11: 0 reports for this device; peer average 1.39/device2024-12: 0 reports for this device; peer average 1.45/device2025-01: 0 reports for this device; peer average 1.64/device2025-02: 0 reports for this device; peer average 1.43/device2025-03: 0 reports for this device; peer average 1.71/device2025-04: 0 reports for this device; peer average 1.65/device2025-05: 0 reports for this device; peer average 1.44/device2025-06: 0 reports for this device; peer average 1.66/device2025-07: 0 reports for this device; peer average 1.59/device2025-08: 0 reports for this device; peer average 1.44/device2025-09: 0 reports for this device; peer average 1.48/device2025-10: 0 reports for this device; peer average 1.47/device2025-11: 0 reports for this device; peer average 1.59/device2025-12: 0 reports for this device; peer average 1.76/device2026-01: 0 reports for this device; peer average 1.61/device2026-02: 0 reports for this device; peer average 1.46/device2026-03: 0 reports for this device; peer average 1.87/device2026-04: 0 reports for this device; peer average 1.67/device2026-05: 0 reports for this device; peer average 1.46/device2026-06: 0 reports for this device; peer average 1.61/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.76
2019-0201.61
2019-0301.73
2019-0401.93
2019-0501.6
2019-0601.3
2019-0701.4
2019-0801.61
2019-0901.47
2019-1001.57
2019-1101.66
2019-1201.55
2020-0101.57
2020-0201.55
2020-0301.84
2020-0401.52
2020-0501.32
2020-0601.45
2020-0701.72
2020-0801.48
2020-0901.61
2020-1001.61
2020-1101.48
2020-1201.56
2021-0101.54
2021-0201.43
2021-0301.46
2021-0401.53
2021-0501.53
2021-0601.6
2021-0701.46
2021-0801.39
2021-0901.84
2021-1001.51
2021-1101.5
2021-1201.4
2022-0101.37
2022-0201.47
2022-0301.44
2022-0401.41
2022-0501.64
2022-0601.55
2022-0701.44
2022-0801.65
2022-0901.67
2022-1001.59
2022-1101.68
2022-1201.37
2023-0101.35
2023-0201.48
2023-0301.64
2023-0401.79
2023-0501.68
2023-0601.9
2023-0701.9
2023-0801.71
2023-0901.82
2023-1001.42
2023-1101.36
2023-1201.4
2024-0101.47
2024-0201.67
2024-0301.88
2024-0401.63
2024-0502.19
2024-0601.9
2024-0701.51
2024-0801.99
2024-0901.82
2024-1001.66
2024-1101.39
2024-1201.45
2025-0101.64
2025-0201.43
2025-0301.71
2025-0401.65
2025-0501.44
2025-0601.66
2025-0701.59
2025-0801.44
2025-0901.48
2025-1001.47
2025-1101.59
2025-1201.76
2026-0101.61
2026-0201.46
2026-0301.87
2026-0401.67
2026-0501.46
2026-0601.61
This device (reports/month)Average device in MEH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K080980 — cited as predicate by K103012, K113320, K121297, K153649

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

Manufacturer compliance record — Exactech, Inc.

  • Warning Letter 2025-12-19 Exactech Sarasota, Inc.
  • Warning Letter 2024-01-19 Exactech, Inc.
  • Warning Letter 2024-01-19 Exactech, Inc.
  • OAI 2025-08-27 Exactech, Inc. · 9 citations
  • OAI 2025-08-27 Exactech, Inc. · 9 citations
  • OAI 2025-07-25 Exactech Sarasota, Inc. · 7 citations
  • VAI 2024-10-09 Exactech, Inc. · 0 citations
  • VAI 2024-10-09 Exactech, Inc. · 0 citations
  • OAI 2023-09-26 Exactech, Inc. · 2 citations
  • OAI 2023-09-26 Exactech, Inc. · 2 citations
  • VAI 2021-11-17 Exactech, Inc. · 4 citations
  • VAI 2021-11-17 Exactech, Inc. · 4 citations
  • VAI 2020-01-31 Exactech, Inc. · 7 citations
  • VAI 2020-01-31 Exactech, Inc. · 7 citations
  • VAI 2017-03-10 Exactech, Inc. · 7 citations
  • VAI 2017-03-10 Exactech, Inc. · 7 citations
  • NAI 2015-07-16 Exactech, Inc. · 0 citations
  • NAI 2015-07-16 Exactech, Inc. · 0 citations
  • NAI 2014-08-25 Exactech Sarasota, Inc. · 0 citations
  • NAI 2012-12-11 Exactech, Inc. · 0 citations
  • NAI 2012-12-11 Exactech, Inc. · 0 citations
  • VAI 2010-03-25 Exactech, Inc. · 0 citations
  • VAI 2010-03-25 Exactech, Inc. · 0 citations