# K232897: Arthrex Small External Fixation System

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Oct 18, 2023 after 30 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K961916 (1996). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141912: Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon, Advanced Orthopaedic Solutions, Inc. (2014) Summary page 4.

## Indications for use
Arthrex Small External Fixation System is intended to be used in the stabilization of open and/or unstable fractures in anatomies such as the hand, wrist, forearm, foot, and ankle where soft tissue injury may preclude the use of other fracture treatments. The Arthrex Small External Fixation System is intended to be non-weight bearing.

Source page: https://510kreport.com/device/K232897
Methodology: https://510kreport.com/methodology