Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

TRIGEN

Model 71655037 · Smith & Nephew, Inc. · DI 03596010585516

JDS — Nail, Fixation, Bone · Class II · 21 CFR 888.3030

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2020-06-24Z-2685-2020Class IITerminatedA manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.k number procode

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.

23572019-01: 0 reports for this device; peer average 1.43/device2019-02: 0 reports for this device; peer average 1.65/device2019-03: 0 reports for this device; peer average 1.25/device2019-04: 0 reports for this device; peer average 1.14/device2019-05: 0 reports for this device; peer average 2.3/device2019-06: 0 reports for this device; peer average 1.88/device2019-07: 0 reports for this device; peer average 2.4/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1.27/device2019-10: 0 reports for this device; peer average 2.07/device2019-11: 0 reports for this device; peer average 2.36/device2019-12: 0 reports for this device; peer average 2.08/device2020-01: 0 reports for this device; peer average 1.4/device2020-02: 0 reports for this device; peer average 2.17/device2020-03: 0 reports for this device; peer average 1.67/device2020-04: 0 reports for this device; peer average 1.86/device2020-05: 0 reports for this device; peer average 1.25/device2020-06: 0 reports for this device; peer average 2.25/device2020-07: 0 reports for this device; peer average 1.85/device2020-08: 0 reports for this device; peer average 1.88/device2020-09: 0 reports for this device; peer average 2.78/device2020-10: 0 reports for this device; peer average 1.9/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 1.65/device2021-01: 0 reports for this device; peer average 1.71/device2021-02: 0 reports for this device; peer average 1.83/device2021-03: 0 reports for this device; peer average 1.89/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 2.13/device2021-06: 0 reports for this device; peer average 1.87/device2021-07: 0 reports for this device; peer average 1.79/device2021-08: 0 reports for this device; peer average 3.06/device2021-09: 0 reports for this device; peer average 1.96/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1.78/device2021-12: 0 reports for this device; peer average 2.18/device2022-01: 0 reports for this device; peer average 2.07/device2022-02: 0 reports for this device; peer average 2.5/device2022-03: 0 reports for this device; peer average 1.9/device2022-04: 0 reports for this device; peer average 1.68/device2022-05: 0 reports for this device; peer average 1.7/device2022-06: 0 reports for this device; peer average 2.42/device2022-07: 0 reports for this device; peer average 2.22/device2022-08: 0 reports for this device; peer average 2.4/device2022-09: 0 reports for this device; peer average 3.96/device2022-10: 0 reports for this device; peer average 3.06/device2022-11: 0 reports for this device; peer average 3.82/device2022-12: 0 reports for this device; peer average 3.08/device2023-01: 0 reports for this device; peer average 3.14/device2023-02: 0 reports for this device; peer average 3.93/device2023-03: 0 reports for this device; peer average 4.56/device2023-04: 0 reports for this device; peer average 3.09/device2023-05: 0 reports for this device; peer average 4.53/device2023-06: 0 reports for this device; peer average 4.15/device2023-07: 0 reports for this device; peer average 3.1/device2023-08: 0 reports for this device; peer average 2.11/device2023-09: 0 reports for this device; peer average 1.82/device2023-10: 0 reports for this device; peer average 1.81/device2023-11: 0 reports for this device; peer average 1.33/device2023-12: 0 reports for this device; peer average 1.85/device2024-01: 0 reports for this device; peer average 2.88/device2024-02: 0 reports for this device; peer average 1.81/device2024-03: 0 reports for this device; peer average 2.18/device2024-04: 0 reports for this device; peer average 1.83/device2024-05: 0 reports for this device; peer average 1.67/device2024-06: 0 reports for this device; peer average 2.25/device2024-07: 0 reports for this device; peer average 1.5/device2024-08: 0 reports for this device; peer average 1.88/device2024-09: 0 reports for this device; peer average 2.21/device2024-10: 0 reports for this device; peer average 2.38/device2024-11: 0 reports for this device; peer average 3.08/device2024-12: 0 reports for this device; peer average 2.59/device2025-01: 0 reports for this device; peer average 3.33/device2025-02: 0 reports for this device; peer average 2.75/device2025-03: 0 reports for this device; peer average 2.54/device2025-04: 0 reports for this device; peer average 6.64/device2025-05: 0 reports for this device; peer average 2.89/device2025-06: 0 reports for this device; peer average 2.2/device2025-07: 0 reports for this device; peer average 3.18/device2025-08: 0 reports for this device; peer average 2.61/device2025-09: 0 reports for this device; peer average 3.09/device2025-10: 0 reports for this device; peer average 3.22/device2025-11: 0 reports for this device; peer average 3.29/device2025-12: 0 reports for this device; peer average 3.93/device2026-01: 0 reports for this device; peer average 2.75/device2026-02: 0 reports for this device; peer average 3.13/device2026-03: 0 reports for this device; peer average 2.2/device2026-04: 0 reports for this device; peer average 2.07/device2026-05: 0 reports for this device; peer average 2.58/device2026-06: 0 reports for this device; peer average 2.43/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.43
2019-0201.65
2019-0301.25
2019-0401.14
2019-0502.3
2019-0601.88
2019-0702.4
2019-0802
2019-0901.27
2019-1002.07
2019-1102.36
2019-1202.08
2020-0101.4
2020-0202.17
2020-0301.67
2020-0401.86
2020-0501.25
2020-0602.25
2020-0701.85
2020-0801.88
2020-0902.78
2020-1001.9
2020-1102
2020-1201.65
2021-0101.71
2021-0201.83
2021-0301.89
2021-0402
2021-0502.13
2021-0601.87
2021-0701.79
2021-0803.06
2021-0901.96
2021-1002
2021-1101.78
2021-1202.18
2022-0102.07
2022-0202.5
2022-0301.9
2022-0401.68
2022-0501.7
2022-0602.42
2022-0702.22
2022-0802.4
2022-0903.96
2022-1003.06
2022-1103.82
2022-1203.08
2023-0103.14
2023-0203.93
2023-0304.56
2023-0403.09
2023-0504.53
2023-0604.15
2023-0703.1
2023-0802.11
2023-0901.82
2023-1001.81
2023-1101.33
2023-1201.85
2024-0102.88
2024-0201.81
2024-0302.18
2024-0401.83
2024-0501.67
2024-0602.25
2024-0701.5
2024-0801.88
2024-0902.21
2024-1002.38
2024-1103.08
2024-1202.59
2025-0103.33
2025-0202.75
2025-0302.54
2025-0406.64
2025-0502.89
2025-0602.2
2025-0703.18
2025-0802.61
2025-0903.09
2025-1003.22
2025-1103.29
2025-1203.93
2026-0102.75
2026-0203.13
2026-0302.2
2026-0402.07
2026-0502.58
2026-0602.43
This device (reports/month)Average device in JDS (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K061019 — cited as predicate by K092748, K102369, K111667, K150867, K171108, K210980, K230761, K240061

K210980 — cites (transitively): K032722 (d1), K040212 (d1), K040929 (d1), K043052 (d1), K050938 (d1), K051557 (d1), K061019 (d1), K111025 (d1), K981529 (d1), K092748 (d2), K983942 (d2), K010801 (d3), K040462 (d3), K050226 (d3)

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

Manufacturer compliance record — Smith & Nephew, Inc.

  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2014-06-11 Smith & Nephew, Inc.
  • Warning Letter 2010-09-16 Ascension Orthopedics, Inc
  • NAI 2025-01-27 Integrity Orthopaedics Inc · 0 citations
  • NAI 2023-05-03 CARTIHEAL, LTD · 0 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • VAI 2020-02-06 Blue Belt Technologies, Inc · 6 citations
  • NAI 2019-10-25 Tusker Medical, Inc. · 0 citations
  • VAI 2019-10-08 Tusker Medical, Inc. · 3 citations
  • NAI 2018-03-30 Ascension Orthopedics, Inc · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-01-30 Smith & Nephew · 0 citations
  • NAI 2017-08-21 Smith & Nephew, Inc. Advanced Surgical Devices Division · 0 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations