# K231339: Tyber Medical Pin and Wire System (various)

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Jul 6, 2023 after 59 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
Longest line of descent: 3 generations back to K961522 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083490: Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685, Biopro, Inc. (2009) Summary page 4.
- K100736: Kirschner and Guide Wires, Smt Schilling Metalltechnik GmbH (2010) Summary page 4.

## Indications for use
The Tyber Medical Pin and Wire System is indicated for use in fixation of small bone fractures (e.g., small bone fragment(s) of hand or foot), bone reconstructions, and as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Source page: https://510kreport.com/device/K231339
Methodology: https://510kreport.com/methodology