# K203605: SteriTrak

- Pathway: 510(k) (Traditional)
- Applicant: Arbutus Medical, Inc.
- Decided: Apr 23, 2021 after 134 days
- Product code: JEC (Component, Traction, Invasive)
- 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 K761088 (1976). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 4.
- K761088: Depuy Modified Skeletal Traction Pin, Depuy, Inc. (1976) Summary page 4.

## Indications for use
SteriTrak is indicated for implantation through the skin and bone so that traction may be applied to the skeletal system.

Source page: https://510kreport.com/device/K203605
Methodology: https://510kreport.com/methodology