# K121008: Trilliant Surgical K-Wires

- Pathway: 510(k) (Traditional)
- Applicant: Trilliant Surgical, Ltd.
- Decided: Jun 4, 2012 after 62 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K960385 (1996). 4 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030336: Kmedic External Fixation Devices, Teleflex Medical Group (2003) Summary page 1.

## Most influential descendants
- K161449: HammerTech Fixation System (2016), 5 descendants of its own
- K201850: Vector Hammertoe Correction System (2020), 3 descendants of its own
- K213421: Vector® Hammertoe Correction System (2021), 2 descendants of its own
- K231453: SnapHammer Hammertoe Correction System (2024), 1 descendant of its own
- K250613: SnapHammer Hammertoe Correction System (2025), 0 descendants of its own

## Recalls of this device
- Nov 4, 2019 · Class II · Z-1635-2020: 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 

## Indications for use
The Trilliant Surgical K-wires are intended for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants.

Source page: https://510kreport.com/device/K121008
Methodology: https://510kreport.com/methodology