# K241014: Biomet Kirschner Wires (K-Wires)

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: May 22, 2024 after 40 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: 2 generations back to K831005 (1983). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143618: Kirschner Wires, Steinmann Pins, Zimmer, Inc. (2015) Summary page 4.

## Most influential descendants
- K253718: enHAnce PEEK Bunion System (2026), 1 descendant of its own
- K262098: EnHAnce PEEK Bunion System (2026), 0 descendants of its own

## Indications for use
Kirschner Wires are used for; As guide pins for insertion of other implants Bone reconstructions Fixation of bone fractures and osteotomies Implanted through the skin for traction applied to the skeletal system

Source page: https://510kreport.com/device/K241014
Methodology: https://510kreport.com/methodology