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15mm x 12mm x 12mm Staple

Model 500-15-102 · Trilliant Surgical, LLC · DI 00812926028248

JDR — Staple, Fixation, Bone · Class II · 21 CFR 888.3030

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.

24572019-01: 0 reports for this device; peer average 3.43/device2019-02: 0 reports for this device; peer average 1.59/device2019-03: 0 reports for this device; peer average 2.17/device2019-04: 0 reports for this device; peer average 2.6/device2019-05: 0 reports for this device; peer average 2.06/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2.17/device2019-08: 0 reports for this device; peer average 1.97/device2019-09: 0 reports for this device; peer average 2.88/device2019-10: 0 reports for this device; peer average 2.58/device2019-11: 0 reports for this device; peer average 2.43/device2019-12: 0 reports for this device; peer average 2.66/device2020-01: 0 reports for this device; peer average 2.43/device2020-02: 0 reports for this device; peer average 2.5/device2020-03: 0 reports for this device; peer average 2.5/device2020-04: 0 reports for this device; peer average 3.56/device2020-05: 0 reports for this device; peer average 2.27/device2020-06: 0 reports for this device; peer average 2.94/device2020-07: 0 reports for this device; peer average 2.2/device2020-08: 0 reports for this device; peer average 2.95/device2020-09: 0 reports for this device; peer average 2.58/device2020-10: 0 reports for this device; peer average 2.7/device2020-11: 0 reports for this device; peer average 3.63/device2020-12: 0 reports for this device; peer average 3.2/device2021-01: 0 reports for this device; peer average 2.14/device2021-02: 0 reports for this device; peer average 2.88/device2021-03: 0 reports for this device; peer average 2.74/device2021-04: 0 reports for this device; peer average 2.08/device2021-05: 0 reports for this device; peer average 3.2/device2021-06: 0 reports for this device; peer average 2.91/device2021-07: 0 reports for this device; peer average 2.32/device2021-08: 0 reports for this device; peer average 2.05/device2021-09: 0 reports for this device; peer average 3.35/device2021-10: 0 reports for this device; peer average 2.45/device2021-11: 0 reports for this device; peer average 3.72/device2021-12: 0 reports for this device; peer average 2.88/device2022-01: 0 reports for this device; peer average 3.39/device2022-02: 0 reports for this device; peer average 2.95/device2022-03: 0 reports for this device; peer average 3.19/device2022-04: 0 reports for this device; peer average 2.93/device2022-05: 0 reports for this device; peer average 2.62/device2022-06: 0 reports for this device; peer average 2.61/device2022-07: 0 reports for this device; peer average 2.8/device2022-08: 0 reports for this device; peer average 3.46/device2022-09: 0 reports for this device; peer average 3.33/device2022-10: 0 reports for this device; peer average 4.5/device2022-11: 0 reports for this device; peer average 2.52/device2022-12: 0 reports for this device; peer average 2.79/device2023-01: 0 reports for this device; peer average 4.3/device2023-02: 0 reports for this device; peer average 2.56/device2023-03: 0 reports for this device; peer average 3.29/device2023-04: 0 reports for this device; peer average 3.44/device2023-05: 0 reports for this device; peer average 3.35/device2023-06: 0 reports for this device; peer average 4.83/device2023-07: 0 reports for this device; peer average 2.43/device2023-08: 0 reports for this device; peer average 2.88/device2023-09: 0 reports for this device; peer average 3.62/device2023-10: 0 reports for this device; peer average 2.61/device2023-11: 0 reports for this device; peer average 3.35/device2023-12: 0 reports for this device; peer average 3.17/device2024-01: 0 reports for this device; peer average 3.43/device2024-02: 0 reports for this device; peer average 2.5/device2024-03: 0 reports for this device; peer average 3.09/device2024-04: 0 reports for this device; peer average 2.73/device2024-05: 0 reports for this device; peer average 3.03/device2024-06: 0 reports for this device; peer average 3.81/device2024-07: 0 reports for this device; peer average 2.78/device2024-08: 0 reports for this device; peer average 3.86/device2024-09: 0 reports for this device; peer average 3.52/device2024-10: 0 reports for this device; peer average 3.24/device2024-11: 0 reports for this device; peer average 3.84/device2024-12: 0 reports for this device; peer average 3.48/device2025-01: 0 reports for this device; peer average 4.5/device2025-02: 0 reports for this device; peer average 2.76/device2025-03: 0 reports for this device; peer average 3.17/device2025-04: 0 reports for this device; peer average 3/device2025-05: 0 reports for this device; peer average 3.31/device2025-06: 0 reports for this device; peer average 3.33/device2025-07: 0 reports for this device; peer average 3.54/device2025-08: 0 reports for this device; peer average 3.62/device2025-09: 0 reports for this device; peer average 4.14/device2025-10: 0 reports for this device; peer average 3.95/device2025-11: 0 reports for this device; peer average 4.06/device2025-12: 0 reports for this device; peer average 4.14/device2026-01: 0 reports for this device; peer average 4.23/device2026-02: 0 reports for this device; peer average 4.77/device2026-03: 0 reports for this device; peer average 4.19/device2026-04: 0 reports for this device; peer average 3.55/device2026-05: 0 reports for this device; peer average 7.03/device2026-06: 0 reports for this device; peer average 5.16/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.43
2019-0201.59
2019-0302.17
2019-0402.6
2019-0502.06
2019-0602
2019-0702.17
2019-0801.97
2019-0902.88
2019-1002.58
2019-1102.43
2019-1202.66
2020-0102.43
2020-0202.5
2020-0302.5
2020-0403.56
2020-0502.27
2020-0602.94
2020-0702.2
2020-0802.95
2020-0902.58
2020-1002.7
2020-1103.63
2020-1203.2
2021-0102.14
2021-0202.88
2021-0302.74
2021-0402.08
2021-0503.2
2021-0602.91
2021-0702.32
2021-0802.05
2021-0903.35
2021-1002.45
2021-1103.72
2021-1202.88
2022-0103.39
2022-0202.95
2022-0303.19
2022-0402.93
2022-0502.62
2022-0602.61
2022-0702.8
2022-0803.46
2022-0903.33
2022-1004.5
2022-1102.52
2022-1202.79
2023-0104.3
2023-0202.56
2023-0303.29
2023-0403.44
2023-0503.35
2023-0604.83
2023-0702.43
2023-0802.88
2023-0903.62
2023-1002.61
2023-1103.35
2023-1203.17
2024-0103.43
2024-0202.5
2024-0303.09
2024-0402.73
2024-0503.03
2024-0603.81
2024-0702.78
2024-0803.86
2024-0903.52
2024-1003.24
2024-1103.84
2024-1203.48
2025-0104.5
2025-0202.76
2025-0303.17
2025-0403
2025-0503.31
2025-0603.33
2025-0703.54
2025-0803.62
2025-0904.14
2025-1003.95
2025-1104.06
2025-1204.14
2026-0104.23
2026-0204.77
2026-0304.19
2026-0403.55
2026-0507.03
2026-0605.16
This device (reports/month)Average device in JDR (reports/device/month)

Regulatory clearances

  • K172405 SESE 2017-12-11 (k number procode)

Predicate lineage

K172405 — cites (transitively): K081510 (d1), K121452 (d1), K123926 (d1), K153338 (d1), K162354 (d1), K091614 (d2), K021556 (d2), K063298 (d2), K112737 (d2), K151021 (d2), K962011 (d2), K963172 (d2), K963192 (d2), K123363 (d2), K050636 (d3), K062863 (d3), K954330 (d3) — cited as predicate by K181815

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