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Trajectory Wire, DynaFuse

Model 3100-04-0001 · Medshape, Inc. · DI M97031000400010

LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540

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.

13452019-01: 0 reports for this device; peer average 2.43/device2019-02: 0 reports for this device; peer average 2.31/device2019-03: 0 reports for this device; peer average 2.25/device2019-04: 0 reports for this device; peer average 2.08/device2019-05: 0 reports for this device; peer average 2.21/device2019-06: 0 reports for this device; peer average 2.28/device2019-07: 0 reports for this device; peer average 2.37/device2019-08: 0 reports for this device; peer average 2.23/device2019-09: 0 reports for this device; peer average 2.68/device2019-10: 0 reports for this device; peer average 2.1/device2019-11: 0 reports for this device; peer average 2.09/device2019-12: 0 reports for this device; peer average 2.29/device2020-01: 0 reports for this device; peer average 2.34/device2020-02: 0 reports for this device; peer average 2.07/device2020-03: 0 reports for this device; peer average 2.14/device2020-04: 0 reports for this device; peer average 2.25/device2020-05: 0 reports for this device; peer average 2.09/device2020-06: 0 reports for this device; peer average 2.65/device2020-07: 0 reports for this device; peer average 3.62/device2020-08: 0 reports for this device; peer average 3.36/device2020-09: 0 reports for this device; peer average 3.49/device2020-10: 0 reports for this device; peer average 4.02/device2020-11: 0 reports for this device; peer average 3.63/device2020-12: 0 reports for this device; peer average 3.57/device2021-01: 0 reports for this device; peer average 3.73/device2021-02: 0 reports for this device; peer average 3.67/device2021-03: 0 reports for this device; peer average 3.23/device2021-04: 0 reports for this device; peer average 3.49/device2021-05: 0 reports for this device; peer average 3.18/device2021-06: 0 reports for this device; peer average 3.03/device2021-07: 0 reports for this device; peer average 2.66/device2021-08: 0 reports for this device; peer average 3.22/device2021-09: 0 reports for this device; peer average 2.79/device2021-10: 0 reports for this device; peer average 2.52/device2021-11: 0 reports for this device; peer average 3.11/device2021-12: 0 reports for this device; peer average 2.67/device2022-01: 0 reports for this device; peer average 2.6/device2022-02: 0 reports for this device; peer average 3.13/device2022-03: 0 reports for this device; peer average 3.17/device2022-04: 0 reports for this device; peer average 3.52/device2022-05: 0 reports for this device; peer average 3.71/device2022-06: 0 reports for this device; peer average 2.82/device2022-07: 0 reports for this device; peer average 2.5/device2022-08: 0 reports for this device; peer average 2.59/device2022-09: 0 reports for this device; peer average 2.82/device2022-10: 0 reports for this device; peer average 3.08/device2022-11: 0 reports for this device; peer average 3.6/device2022-12: 0 reports for this device; peer average 3.74/device2023-01: 0 reports for this device; peer average 4.57/device2023-02: 0 reports for this device; peer average 3.11/device2023-03: 0 reports for this device; peer average 3.63/device2023-04: 0 reports for this device; peer average 3.08/device2023-05: 0 reports for this device; peer average 3.19/device2023-06: 0 reports for this device; peer average 3.19/device2023-07: 0 reports for this device; peer average 2.85/device2023-08: 0 reports for this device; peer average 2.89/device2023-09: 0 reports for this device; peer average 2.22/device2023-10: 0 reports for this device; peer average 2.4/device2023-11: 0 reports for this device; peer average 3.21/device2023-12: 0 reports for this device; peer average 3.04/device2024-01: 0 reports for this device; peer average 2.84/device2024-02: 0 reports for this device; peer average 3.03/device2024-03: 0 reports for this device; peer average 2.79/device2024-04: 0 reports for this device; peer average 3.59/device2024-05: 0 reports for this device; peer average 3.57/device2024-06: 0 reports for this device; peer average 3.68/device2024-07: 0 reports for this device; peer average 2.83/device2024-08: 0 reports for this device; peer average 2.74/device2024-09: 0 reports for this device; peer average 3.06/device2024-10: 0 reports for this device; peer average 3.11/device2024-11: 0 reports for this device; peer average 2.81/device2024-12: 0 reports for this device; peer average 2.56/device2025-01: 0 reports for this device; peer average 2.86/device2025-02: 0 reports for this device; peer average 4.24/device2025-03: 0 reports for this device; peer average 5.06/device2025-04: 0 reports for this device; peer average 2.79/device2025-05: 0 reports for this device; peer average 2.85/device2025-06: 0 reports for this device; peer average 2.78/device2025-07: 0 reports for this device; peer average 2.56/device2025-08: 0 reports for this device; peer average 2.6/device2025-09: 0 reports for this device; peer average 2.15/device2025-10: 0 reports for this device; peer average 2.32/device2025-11: 0 reports for this device; peer average 2.66/device2025-12: 0 reports for this device; peer average 3.79/device2026-01: 0 reports for this device; peer average 3.54/device2026-02: 0 reports for this device; peer average 3.48/device2026-03: 0 reports for this device; peer average 3.22/device2026-04: 0 reports for this device; peer average 3.13/device2026-05: 0 reports for this device; peer average 2.6/device2026-06: 0 reports for this device; peer average 3.35/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.43
2019-0202.31
2019-0302.25
2019-0402.08
2019-0502.21
2019-0602.28
2019-0702.37
2019-0802.23
2019-0902.68
2019-1002.1
2019-1102.09
2019-1202.29
2020-0102.34
2020-0202.07
2020-0302.14
2020-0402.25
2020-0502.09
2020-0602.65
2020-0703.62
2020-0803.36
2020-0903.49
2020-1004.02
2020-1103.63
2020-1203.57
2021-0103.73
2021-0203.67
2021-0303.23
2021-0403.49
2021-0503.18
2021-0603.03
2021-0702.66
2021-0803.22
2021-0902.79
2021-1002.52
2021-1103.11
2021-1202.67
2022-0102.6
2022-0203.13
2022-0303.17
2022-0403.52
2022-0503.71
2022-0602.82
2022-0702.5
2022-0802.59
2022-0902.82
2022-1003.08
2022-1103.6
2022-1203.74
2023-0104.57
2023-0203.11
2023-0303.63
2023-0403.08
2023-0503.19
2023-0603.19
2023-0702.85
2023-0802.89
2023-0902.22
2023-1002.4
2023-1103.21
2023-1203.04
2024-0102.84
2024-0203.03
2024-0302.79
2024-0403.59
2024-0503.57
2024-0603.68
2024-0702.83
2024-0802.74
2024-0903.06
2024-1003.11
2024-1102.81
2024-1202.56
2025-0102.86
2025-0204.24
2025-0305.06
2025-0402.79
2025-0502.85
2025-0602.78
2025-0702.56
2025-0802.6
2025-0902.15
2025-1002.32
2025-1102.66
2025-1203.79
2026-0103.54
2026-0203.48
2026-0303.22
2026-0403.13
2026-0502.6
2026-0603.35
This device (reports/month)Average device in LXH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K203595 — cites (transitively): K133842 (d1), K153338 (d1), K153575 (d1), K973309 (d2), K021556 (d2), K063298 (d2), K081510 (d2), K112737 (d2), K151021 (d2), K962011 (d2), K963172 (d2), K963192 (d2), K153180 (d2), K050636 (d3), K062863 (d3), K954330 (d3) — cited as predicate by K252699, K254110

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

Manufacturer compliance record — Medshape, Inc.

  • NAI 2026-02-13 Medshape, INC. · 0 citations
  • NAI 2026-02-13 Medshape, INC. · 0 citations
  • NAI 2019-04-16 Medshape, INC. · 0 citations
  • NAI 2019-04-16 Medshape, INC. · 0 citations
  • NAI 2015-05-21 Medshape, INC. · 0 citations
  • NAI 2015-05-21 Medshape, INC. · 0 citations
  • NAI 2010-12-03 Medshape, INC. · 0 citations
  • NAI 2010-12-03 Medshape, INC. · 0 citations