# K161489: Syntorr K-wire and Pin System

- Pathway: 510(k) (Traditional)
- Applicant: Syntorr, Inc.
- Decided: Sep 16, 2016 after 107 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Syntorr K-wire and Pin System is indicated for use in open and percutaneous fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants, for implantation through the skin, and as traction pins so that traction may be applied to the skeletal system.

Source page: https://510kreport.com/device/K161489
Methodology: https://510kreport.com/methodology