# K143618: Kirschner Wires, Steinmann Pins

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Feb 6, 2015 after 49 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: 1 generation back to K831005 (1983). 1 ancestor in all.
7 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831005: Wire & Steinman Pins, Kirschner Medical Corp. (1983) Summary page 4.

## Most influential descendants
- K241014: Biomet Kirschner Wires (K-Wires) (2024), 2 descendants of its own
- K253718: enHAnce PEEK Bunion System (2026), 1 descendant of its own
- K151848: Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System (2016), 1 descendant of its own
- K262098: EnHAnce PEEK Bunion System (2026), 0 descendants of its own
- K261271: Cable-Ready® Cable Grip System (2026), 0 descendants of its own

## Indications for use
Kirschner wires (K-Wires) and Steinmann pins are used for fixation of bone fractures, bone reconstruction, as guide pins for insertion of other implants, or to be implanted through the skin so that traction may be applied to the skeletal system. The pins and wires may be used in the threaded or unthreaded form depending upon the desired application.

Source page: https://510kreport.com/device/K143618
Methodology: https://510kreport.com/methodology