# K181898: Two-Step Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Trilliant Surgical
- Decided: Oct 26, 2018 after 102 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K013888 (2002). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122959: Hammer Toe Implant, Trilliant Surgical, Ltd. (2012) Summary page 4.
- K112737: Tiger Headless Cannulated Screws, Trilliant Surgical, Ltd. (2011) Summary page 4.
- K121008: Trilliant Surgical K-Wires, Trilliant Surgical, Ltd. (2012) Summary page 4.
- K030336: Kmedic External Fixation Devices, Teleflex Medical Group (2003) Summary page 4.

## Indications for use
The Two-Step Implant System is intended for fixation of osteotomies and reconstruction of the bones of the foot and hand during procedures to correct deformities of the toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.

Source page: https://510kreport.com/device/K181898
Methodology: https://510kreport.com/methodology