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Equinoxe

Model 321-17-30 · Exactech, Inc. · DI 10885862169334

KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660

KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650

PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660

UDILibrary device dossier · generated 2026-09-13 · 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.

11232019-01: 0 reports for this device; peer average 1.83/device2019-02: 0 reports for this device; peer average 1.78/device2019-03: 0 reports for this device; peer average 1.68/device2019-04: 0 reports for this device; peer average 1.95/device2019-05: 0 reports for this device; peer average 2.13/device2019-06: 0 reports for this device; peer average 1.89/device2019-07: 0 reports for this device; peer average 1.69/device2019-08: 0 reports for this device; peer average 2.18/device2019-09: 0 reports for this device; peer average 1.67/device2019-10: 0 reports for this device; peer average 1.91/device2019-11: 0 reports for this device; peer average 1.68/device2019-12: 0 reports for this device; peer average 1.81/device2020-01: 0 reports for this device; peer average 1.94/device2020-02: 0 reports for this device; peer average 2.07/device2020-03: 0 reports for this device; peer average 2.16/device2020-04: 0 reports for this device; peer average 1.75/device2020-05: 0 reports for this device; peer average 1.71/device2020-06: 0 reports for this device; peer average 2.03/device2020-07: 0 reports for this device; peer average 2.21/device2020-08: 0 reports for this device; peer average 1.84/device2020-09: 0 reports for this device; peer average 2.01/device2020-10: 0 reports for this device; peer average 2.25/device2020-11: 0 reports for this device; peer average 1.95/device2020-12: 0 reports for this device; peer average 1.88/device2021-01: 0 reports for this device; peer average 2.19/device2021-02: 0 reports for this device; peer average 1.91/device2021-03: 0 reports for this device; peer average 2.09/device2021-04: 0 reports for this device; peer average 2.01/device2021-05: 0 reports for this device; peer average 1.92/device2021-06: 0 reports for this device; peer average 1.84/device2021-07: 0 reports for this device; peer average 2.11/device2021-08: 0 reports for this device; peer average 2.23/device2021-09: 0 reports for this device; peer average 1.96/device2021-10: 0 reports for this device; peer average 2.18/device2021-11: 0 reports for this device; peer average 2.07/device2021-12: 0 reports for this device; peer average 2.55/device2022-01: 0 reports for this device; peer average 2.6/device2022-02: 0 reports for this device; peer average 2.39/device2022-03: 0 reports for this device; peer average 2.46/device2022-04: 0 reports for this device; peer average 2.43/device2022-05: 0 reports for this device; peer average 2.06/device2022-06: 0 reports for this device; peer average 2.31/device2022-07: 0 reports for this device; peer average 2.22/device2022-08: 0 reports for this device; peer average 2.24/device2022-09: 0 reports for this device; peer average 2.03/device2022-10: 0 reports for this device; peer average 2.03/device2022-11: 0 reports for this device; peer average 2.13/device2022-12: 0 reports for this device; peer average 2.09/device2023-01: 0 reports for this device; peer average 1.83/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 1.98/device2023-04: 0 reports for this device; peer average 2.14/device2023-05: 0 reports for this device; peer average 2.06/device2023-06: 0 reports for this device; peer average 2.23/device2023-07: 0 reports for this device; peer average 2.09/device2023-08: 0 reports for this device; peer average 1.75/device2023-09: 0 reports for this device; peer average 1.57/device2023-10: 0 reports for this device; peer average 1.61/device2023-11: 0 reports for this device; peer average 1.69/device2023-12: 0 reports for this device; peer average 1.44/device2024-01: 0 reports for this device; peer average 1.85/device2024-02: 0 reports for this device; peer average 1.91/device2024-03: 0 reports for this device; peer average 1.71/device2024-04: 0 reports for this device; peer average 1.87/device2024-05: 0 reports for this device; peer average 1.72/device2024-06: 0 reports for this device; peer average 1.89/device2024-07: 0 reports for this device; peer average 1.63/device2024-08: 0 reports for this device; peer average 1.71/device2024-09: 0 reports for this device; peer average 1.75/device2024-10: 0 reports for this device; peer average 1.74/device2024-11: 0 reports for this device; peer average 1.67/device2024-12: 0 reports for this device; peer average 1.71/device2025-01: 0 reports for this device; peer average 1.75/device2025-02: 0 reports for this device; peer average 1.68/device2025-03: 0 reports for this device; peer average 1.9/device2025-04: 0 reports for this device; peer average 1.82/device2025-05: 0 reports for this device; peer average 1.9/device2025-06: 0 reports for this device; peer average 1.93/device2025-07: 0 reports for this device; peer average 1.74/device2025-08: 0 reports for this device; peer average 1.67/device2025-09: 0 reports for this device; peer average 1.49/device2025-10: 0 reports for this device; peer average 1.66/device2025-11: 0 reports for this device; peer average 1.74/device2025-12: 0 reports for this device; peer average 2.16/device2026-01: 0 reports for this device; peer average 1.9/device2026-02: 0 reports for this device; peer average 1.79/device2026-03: 0 reports for this device; peer average 1.79/device2026-04: 0 reports for this device; peer average 1.73/device2026-05: 0 reports for this device; peer average 1.76/device2026-06: 0 reports for this device; peer average 1.75/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.83
2019-0201.78
2019-0301.68
2019-0401.95
2019-0502.13
2019-0601.89
2019-0701.69
2019-0802.18
2019-0901.67
2019-1001.91
2019-1101.68
2019-1201.81
2020-0101.94
2020-0202.07
2020-0302.16
2020-0401.75
2020-0501.71
2020-0602.03
2020-0702.21
2020-0801.84
2020-0902.01
2020-1002.25
2020-1101.95
2020-1201.88
2021-0102.19
2021-0201.91
2021-0302.09
2021-0402.01
2021-0501.92
2021-0601.84
2021-0702.11
2021-0802.23
2021-0901.96
2021-1002.18
2021-1102.07
2021-1202.55
2022-0102.6
2022-0202.39
2022-0302.46
2022-0402.43
2022-0502.06
2022-0602.31
2022-0702.22
2022-0802.24
2022-0902.03
2022-1002.03
2022-1102.13
2022-1202.09
2023-0101.83
2023-0202
2023-0301.98
2023-0402.14
2023-0502.06
2023-0602.23
2023-0702.09
2023-0801.75
2023-0901.57
2023-1001.61
2023-1101.69
2023-1201.44
2024-0101.85
2024-0201.91
2024-0301.71
2024-0401.87
2024-0501.72
2024-0601.89
2024-0701.63
2024-0801.71
2024-0901.75
2024-1001.74
2024-1101.67
2024-1201.71
2025-0101.75
2025-0201.68
2025-0301.9
2025-0401.82
2025-0501.9
2025-0601.93
2025-0701.74
2025-0801.67
2025-0901.49
2025-1001.66
2025-1101.74
2025-1202.16
2026-0101.9
2026-0201.79
2026-0301.79
2026-0401.73
2026-0501.76
2026-0601.75
This device (reports/month)Average device in KWS, KWT, PHX (reports/device/month)

Regulatory clearances

  • K110708 SESE 2011-04-01 (k number procode)

Predicate lineage

K103419 — cites (transitively): K042021 (d1), K061454 (d1), K093430 (d1) — cited as predicate by K111379, K162567, K222592

K110708 — cited as predicate by K161742, K162325, K162567, K172502, K180632, K193098, K211359

K111379 — cites (transitively): K093430 (d1), K103419 (d1), K042021 (d2), K061454 (d2) — cited as predicate by K212356, K222592

K113309 — cites (transitively): K093430 (d1) — cited as predicate by K162567, K212356

K121220 — cites (transitively): K093430 (d1) — cited as predicate by K162567, K191811, K192365, K212356, K222592

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