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0.062" x 6" K-Wire Partially Threaded
Model 210-60-005 · Trilliant Surgical, LLC · DI 00812926023953
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 (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2019-11-04
Z-1635-2020
Class II
Terminated
The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain (2) reamers total, (1) Concave Reamer and (1) Convex Reamer; there is the potential that kits from the identified lot may have (2) of the same reamer type as opposed to one (1) of each type.
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
4.49
2019-02
0
1.41
2019-03
0
1.42
2019-04
0
1.78
2019-05
0
2.05
2019-06
0
1.62
2019-07
0
2.14
2019-08
0
2
2019-09
0
3.36
2019-10
0
2.7
2019-11
0
3.24
2019-12
0
2.28
2020-01
0
2.08
2020-02
0
1.65
2020-03
0
2.33
2020-04
0
3.55
2020-05
0
1.82
2020-06
0
3.1
2020-07
0
2.36
2020-08
0
2.36
2020-09
0
1.91
2020-10
0
1.95
2020-11
0
3.5
2020-12
0
3
2021-01
0
3.21
2021-02
0
2
2021-03
0
1.8
2021-04
0
1.92
2021-05
0
2
2021-06
0
2.81
2021-07
0
1.56
2021-08
0
1.54
2021-09
0
2.53
2021-10
0
2.17
2021-11
0
1.77
2021-12
0
2.13
2022-01
0
3.44
2022-02
0
1.71
2022-03
0
3
2022-04
0
2.5
2022-05
0
2.1
2022-06
0
3
2022-07
0
2.12
2022-08
0
4.06
2022-09
0
2.79
2022-10
0
4.32
2022-11
0
2.28
2022-12
0
2.93
2023-01
0
4.82
2023-02
0
2.89
2023-03
0
3.11
2023-04
0
3.31
2023-05
0
3
2023-06
0
3.73
2023-07
0
2.75
2023-08
0
3.79
2023-09
0
3.21
2023-10
0
3.25
2023-11
0
4.3
2023-12
0
3.8
2024-01
0
3.8
2024-02
0
3.2
2024-03
0
3.53
2024-04
0
3.78
2024-05
0
2.96
2024-06
0
3.89
2024-07
0
3.06
2024-08
0
3.27
2024-09
0
3.73
2024-10
0
4.54
2024-11
0
4.15
2024-12
0
5
2025-01
0
5.6
2025-02
0
3.7
2025-03
0
3
2025-04
0
4.2
2025-05
0
3.75
2025-06
0
2.78
2025-07
0
4.1
2025-08
0
4.29
2025-09
0
3.13
2025-10
0
4.13
2025-11
0
5
2025-12
0
4.28
2026-01
0
7.08
2026-02
0
5.77
2026-03
0
4.53
2026-04
0
5.13
2026-05
0
6.25
2026-06
0
7.36
This device (reports/month)Average device in HTY (reports/device/month)
Regulatory clearances
K121008 SESE 2012-06-04 (k number procode)
Predicate lineage
K121008 — cites (transitively): K030336 (d1) — cited as predicate by K122959, K161449, K181898, K182684
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