# K121004: Apex Kirschner Wires and Steinmann Pins

- Pathway: 510(k) (Special)
- Applicant: Apex Tools & Orthopedics Co.
- Decided: Apr 24, 2012 after 21 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: 8 generations back to K962823 (1996). 43 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112254: Apex Kirschner Wires and Steinmann Pins, Apex Tools & Orthopedics Co. (2011) Summary page 2.

## Most influential descendants
- K162032: Arrowhead Mini-Rail Fixator (2017), 1 descendant of its own
- K252106: External Fixation Mini Rail System (2025), 0 descendants of its own

## Indications for use
The Apex Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, 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/K121004
Methodology: https://510kreport.com/methodology