# K102215: Kirschner Wires, Steinman Pins

- Pathway: 510(k) (Traditional)
- Applicant: Evergreen Orthopedic Research Lab
- Decided: Nov 9, 2010 after 95 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 K960385 (1996). 6 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960385: Sterile Kirschner Wires and Steinmann Pins, Depuy, Inc. (1996) Summary page 1.
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 1.
- K070555: Orthopro Steinman Pins and Kirschner Wires, Orthopro, LLC (2007) Summary page 1.
- K030336: Kmedic External Fixation Devices, Teleflex Medical Group (2003) Summary page 1.

## Most influential descendants
- K112254: Apex Kirschner Wires and Steinmann Pins (2011), 5 descendants of its own
- K121004: Apex Kirschner Wires and Steinmann Pins (2012), 2 descendants of its own
- K162032: Arrowhead Mini-Rail Fixator (2017), 1 descendant of its own
- K150443: ToeTac Hammertoe Fixation System (2015), 1 descendant of its own
- K252106: External Fixation Mini Rail System (2025), 0 descendants of its own

## Indications for use
The Operativ 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/K102215
Methodology: https://510kreport.com/methodology