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"0.062"" x 4.65"" Olive Wire Partially Threaded"

Model 320-60-005 · Trilliant Surgical, LLC · DI 00812926026886

HTY — Pin, Fixation, Smooth · Class II · 21 CFR 888.3040

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.

24672019-01: 0 reports for this device; peer average 4.49/device2019-02: 0 reports for this device; peer average 1.41/device2019-03: 0 reports for this device; peer average 1.42/device2019-04: 0 reports for this device; peer average 1.78/device2019-05: 0 reports for this device; peer average 2.05/device2019-06: 0 reports for this device; peer average 1.62/device2019-07: 0 reports for this device; peer average 2.14/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 3.36/device2019-10: 0 reports for this device; peer average 2.7/device2019-11: 0 reports for this device; peer average 3.24/device2019-12: 0 reports for this device; peer average 2.28/device2020-01: 0 reports for this device; peer average 2.08/device2020-02: 0 reports for this device; peer average 1.65/device2020-03: 0 reports for this device; peer average 2.33/device2020-04: 0 reports for this device; peer average 3.55/device2020-05: 0 reports for this device; peer average 1.82/device2020-06: 0 reports for this device; peer average 3.1/device2020-07: 0 reports for this device; peer average 2.36/device2020-08: 0 reports for this device; peer average 2.36/device2020-09: 0 reports for this device; peer average 1.91/device2020-10: 0 reports for this device; peer average 1.95/device2020-11: 0 reports for this device; peer average 3.5/device2020-12: 0 reports for this device; peer average 3/device2021-01: 0 reports for this device; peer average 3.21/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 1.8/device2021-04: 0 reports for this device; peer average 1.92/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2.81/device2021-07: 0 reports for this device; peer average 1.56/device2021-08: 0 reports for this device; peer average 1.54/device2021-09: 0 reports for this device; peer average 2.53/device2021-10: 0 reports for this device; peer average 2.17/device2021-11: 0 reports for this device; peer average 1.77/device2021-12: 0 reports for this device; peer average 2.13/device2022-01: 0 reports for this device; peer average 3.44/device2022-02: 0 reports for this device; peer average 1.71/device2022-03: 0 reports for this device; peer average 3/device2022-04: 0 reports for this device; peer average 2.5/device2022-05: 0 reports for this device; peer average 2.1/device2022-06: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 2.12/device2022-08: 0 reports for this device; peer average 4.06/device2022-09: 0 reports for this device; peer average 2.79/device2022-10: 0 reports for this device; peer average 4.32/device2022-11: 0 reports for this device; peer average 2.28/device2022-12: 0 reports for this device; peer average 2.93/device2023-01: 0 reports for this device; peer average 4.82/device2023-02: 0 reports for this device; peer average 2.89/device2023-03: 0 reports for this device; peer average 3.11/device2023-04: 0 reports for this device; peer average 3.31/device2023-05: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 3.73/device2023-07: 0 reports for this device; peer average 2.75/device2023-08: 0 reports for this device; peer average 3.79/device2023-09: 0 reports for this device; peer average 3.21/device2023-10: 0 reports for this device; peer average 3.25/device2023-11: 0 reports for this device; peer average 4.3/device2023-12: 0 reports for this device; peer average 3.8/device2024-01: 0 reports for this device; peer average 3.8/device2024-02: 0 reports for this device; peer average 3.2/device2024-03: 0 reports for this device; peer average 3.53/device2024-04: 0 reports for this device; peer average 3.78/device2024-05: 0 reports for this device; peer average 2.96/device2024-06: 0 reports for this device; peer average 3.89/device2024-07: 0 reports for this device; peer average 3.06/device2024-08: 0 reports for this device; peer average 3.27/device2024-09: 0 reports for this device; peer average 3.73/device2024-10: 0 reports for this device; peer average 4.54/device2024-11: 0 reports for this device; peer average 4.15/device2024-12: 0 reports for this device; peer average 5/device2025-01: 0 reports for this device; peer average 5.6/device2025-02: 0 reports for this device; peer average 3.7/device2025-03: 0 reports for this device; peer average 3/device2025-04: 0 reports for this device; peer average 4.2/device2025-05: 0 reports for this device; peer average 3.75/device2025-06: 0 reports for this device; peer average 2.78/device2025-07: 0 reports for this device; peer average 4.1/device2025-08: 0 reports for this device; peer average 4.29/device2025-09: 0 reports for this device; peer average 3.13/device2025-10: 0 reports for this device; peer average 4.13/device2025-11: 0 reports for this device; peer average 5/device2025-12: 0 reports for this device; peer average 4.28/device2026-01: 0 reports for this device; peer average 7.08/device2026-02: 0 reports for this device; peer average 5.77/device2026-03: 0 reports for this device; peer average 4.53/device2026-04: 0 reports for this device; peer average 5.13/device2026-05: 0 reports for this device; peer average 6.25/device2026-06: 0 reports for this device; peer average 7.36/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.49
2019-0201.41
2019-0301.42
2019-0401.78
2019-0502.05
2019-0601.62
2019-0702.14
2019-0802
2019-0903.36
2019-1002.7
2019-1103.24
2019-1202.28
2020-0102.08
2020-0201.65
2020-0302.33
2020-0403.55
2020-0501.82
2020-0603.1
2020-0702.36
2020-0802.36
2020-0901.91
2020-1001.95
2020-1103.5
2020-1203
2021-0103.21
2021-0202
2021-0301.8
2021-0401.92
2021-0502
2021-0602.81
2021-0701.56
2021-0801.54
2021-0902.53
2021-1002.17
2021-1101.77
2021-1202.13
2022-0103.44
2022-0201.71
2022-0303
2022-0402.5
2022-0502.1
2022-0603
2022-0702.12
2022-0804.06
2022-0902.79
2022-1004.32
2022-1102.28
2022-1202.93
2023-0104.82
2023-0202.89
2023-0303.11
2023-0403.31
2023-0503
2023-0603.73
2023-0702.75
2023-0803.79
2023-0903.21
2023-1003.25
2023-1104.3
2023-1203.8
2024-0103.8
2024-0203.2
2024-0303.53
2024-0403.78
2024-0502.96
2024-0603.89
2024-0703.06
2024-0803.27
2024-0903.73
2024-1004.54
2024-1104.15
2024-1205
2025-0105.6
2025-0203.7
2025-0303
2025-0404.2
2025-0503.75
2025-0602.78
2025-0704.1
2025-0804.29
2025-0903.13
2025-1004.13
2025-1105
2025-1204.28
2026-0107.08
2026-0205.77
2026-0304.53
2026-0405.13
2026-0506.25
2026-0607.36
This device (reports/month)Average device in HTY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K160177 — cites (transitively): K040860 (d1), K102429 (d1), K121452 (d1), K143385 (d1), K082320 (d2), K091243 (d2), K091614 (d2), K011335 (d2), K083213 (d2), K120854 (d2), K000684 (d3), K033805 (d3), K043185 (d3), K073460 (d3), K120717 (d3), K033995 (d4), K100776 (d4), K120070 (d4), K061808 (d5), K063049 (d5), K090063 (d5), K090675 (d5) — cited as predicate by K191009, K212378

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

Manufacturer compliance record — Trilliant Surgical, LLC

  • Warning Letter 2010-05-03 Trilliant Surgical, LLC
  • Warning Letter 2010-05-03 Trilliant Surgical, LLC
  • VAI 2019-12-11 Trilliant Surgical, LLC · 5 citations
  • VAI 2019-12-11 Trilliant Surgical, LLC · 5 citations
  • VAI 2018-05-02 Trilliant Surgical, LLC · 10 citations
  • VAI 2018-05-02 Trilliant Surgical, LLC · 10 citations
  • OAI 2016-06-27 Trilliant Surgical, LLC · 9 citations
  • OAI 2016-06-27 Trilliant Surgical, LLC · 9 citations
  • OAI 2015-02-12 Trilliant Surgical, LLC · 5 citations
  • OAI 2015-02-12 Trilliant Surgical, LLC · 5 citations
  • VAI 2011-09-09 Trilliant Surgical, LLC · 3 citations
  • VAI 2011-09-09 Trilliant Surgical, LLC · 3 citations
  • OAI 2010-01-20 Trilliant Surgical, LLC · 4 citations
  • OAI 2010-01-20 Trilliant Surgical, LLC · 4 citations