# K092038: Aptus K-Wire System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Sep 23, 2009 after 79 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
No predicates in its family tree.
91 later devices descend from it; 7 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K103332: Aptus Ulna Plates (2011), 71 descendants of its own
- K142906: APTUS Wrist 2.5 System (2015), 59 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own

## Indications for use
The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

Source page: https://510kreport.com/device/K092038
Methodology: https://510kreport.com/methodology