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Equinoxe

Model 313-10-53 · Exactech, Inc. · DI 10885862252319

HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · Class II · 21 CFR 888.3690

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 1.47/device2019-03: 0 reports for this device; peer average 1.62/device2019-04: 0 reports for this device; peer average 1.54/device2019-05: 0 reports for this device; peer average 1.8/device2019-06: 0 reports for this device; peer average 1.79/device2019-07: 0 reports for this device; peer average 1.33/device2019-08: 0 reports for this device; peer average 2.03/device2019-09: 0 reports for this device; peer average 1.58/device2019-10: 0 reports for this device; peer average 1.7/device2019-11: 0 reports for this device; peer average 1.65/device2019-12: 0 reports for this device; peer average 1.68/device2020-01: 0 reports for this device; peer average 2.04/device2020-02: 0 reports for this device; peer average 2.18/device2020-03: 0 reports for this device; peer average 1.45/device2020-04: 0 reports for this device; peer average 1.67/device2020-05: 0 reports for this device; peer average 1.63/device2020-06: 0 reports for this device; peer average 1.87/device2020-07: 0 reports for this device; peer average 1.97/device2020-08: 0 reports for this device; peer average 1.85/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1.86/device2020-11: 0 reports for this device; peer average 1.8/device2020-12: 0 reports for this device; peer average 1.76/device2021-01: 0 reports for this device; peer average 1.91/device2021-02: 0 reports for this device; peer average 2.13/device2021-03: 0 reports for this device; peer average 2.08/device2021-04: 0 reports for this device; peer average 2.03/device2021-05: 0 reports for this device; peer average 1.8/device2021-06: 0 reports for this device; peer average 1.51/device2021-07: 0 reports for this device; peer average 2.02/device2021-08: 0 reports for this device; peer average 2.24/device2021-09: 0 reports for this device; peer average 1.85/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 2.03/device2021-12: 0 reports for this device; peer average 1.91/device2022-01: 0 reports for this device; peer average 2.28/device2022-02: 0 reports for this device; peer average 2.27/device2022-03: 0 reports for this device; peer average 1.85/device2022-04: 0 reports for this device; peer average 2.12/device2022-05: 0 reports for this device; peer average 2.01/device2022-06: 0 reports for this device; peer average 2.08/device2022-07: 0 reports for this device; peer average 2.32/device2022-08: 0 reports for this device; peer average 1.95/device2022-09: 0 reports for this device; peer average 1.92/device2022-10: 0 reports for this device; peer average 1.88/device2022-11: 0 reports for this device; peer average 1.76/device2022-12: 0 reports for this device; peer average 1.79/device2023-01: 0 reports for this device; peer average 1.81/device2023-02: 0 reports for this device; peer average 1.62/device2023-03: 0 reports for this device; peer average 2.02/device2023-04: 0 reports for this device; peer average 1.97/device2023-05: 0 reports for this device; peer average 2.02/device2023-06: 0 reports for this device; peer average 2.12/device2023-07: 0 reports for this device; peer average 1.9/device2023-08: 0 reports for this device; peer average 1.47/device2023-09: 0 reports for this device; peer average 1.31/device2023-10: 0 reports for this device; peer average 1.57/device2023-11: 0 reports for this device; peer average 1.48/device2023-12: 0 reports for this device; peer average 1.35/device2024-01: 0 reports for this device; peer average 1.44/device2024-02: 0 reports for this device; peer average 1.43/device2024-03: 0 reports for this device; peer average 1.41/device2024-04: 0 reports for this device; peer average 1.69/device2024-05: 0 reports for this device; peer average 1.35/device2024-06: 0 reports for this device; peer average 1.84/device2024-07: 0 reports for this device; peer average 1.34/device2024-08: 0 reports for this device; peer average 1.64/device2024-09: 0 reports for this device; peer average 1.42/device2024-10: 0 reports for this device; peer average 1.58/device2024-11: 0 reports for this device; peer average 1.38/device2024-12: 0 reports for this device; peer average 1.4/device2025-01: 0 reports for this device; peer average 1.57/device2025-02: 0 reports for this device; peer average 1.45/device2025-03: 0 reports for this device; peer average 1.68/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 1.5/device2025-06: 0 reports for this device; peer average 1.64/device2025-07: 0 reports for this device; peer average 1.58/device2025-08: 0 reports for this device; peer average 1.48/device2025-09: 0 reports for this device; peer average 1.43/device2025-10: 0 reports for this device; peer average 1.47/device2025-11: 0 reports for this device; peer average 1.79/device2025-12: 0 reports for this device; peer average 2.03/device2026-01: 0 reports for this device; peer average 1.69/device2026-02: 0 reports for this device; peer average 1.75/device2026-03: 0 reports for this device; peer average 1.5/device2026-04: 0 reports for this device; peer average 1.67/device2026-05: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 1.67/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
2019-0201.47
2019-0301.62
2019-0401.54
2019-0501.8
2019-0601.79
2019-0701.33
2019-0802.03
2019-0901.58
2019-1001.7
2019-1101.65
2019-1201.68
2020-0102.04
2020-0202.18
2020-0301.45
2020-0401.67
2020-0501.63
2020-0601.87
2020-0701.97
2020-0801.85
2020-0902
2020-1001.86
2020-1101.8
2020-1201.76
2021-0101.91
2021-0202.13
2021-0302.08
2021-0402.03
2021-0501.8
2021-0601.51
2021-0702.02
2021-0802.24
2021-0901.85
2021-1002
2021-1102.03
2021-1201.91
2022-0102.28
2022-0202.27
2022-0301.85
2022-0402.12
2022-0502.01
2022-0602.08
2022-0702.32
2022-0801.95
2022-0901.92
2022-1001.88
2022-1101.76
2022-1201.79
2023-0101.81
2023-0201.62
2023-0302.02
2023-0401.97
2023-0502.02
2023-0602.12
2023-0701.9
2023-0801.47
2023-0901.31
2023-1001.57
2023-1101.48
2023-1201.35
2024-0101.44
2024-0201.43
2024-0301.41
2024-0401.69
2024-0501.35
2024-0601.84
2024-0701.34
2024-0801.64
2024-0901.42
2024-1001.58
2024-1101.38
2024-1201.4
2025-0101.57
2025-0201.45
2025-0301.68
2025-0401.5
2025-0501.5
2025-0601.64
2025-0701.58
2025-0801.48
2025-0901.43
2025-1001.47
2025-1101.79
2025-1202.03
2026-0101.69
2026-0201.75
2026-0301.5
2026-0401.67
2026-0501.5
2026-0601.67
This device (reports/month)Average device in HSD (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K131298 — cites (transitively): K023096 (d1), K042021 (d1), K093430 (d1) — cited as predicate by K152825, K173388, K182500

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