# K092002: Afghan External Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 10, 2009 after 161 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: 1 generation back to K971962 (1997). 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)
- K971962: Osteo Kirschner Wires, Osteonics Corp. (1997) Summary page 1.
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 1.
- (no number) Smith & Nephew Kirschner Wires - Preamendment: named in the summary without a submission number

## Indications for use
The Afghan External Fixator and its components are intended to be used in adolescents (12-21 years) and adults for securing small bone fractures and bone fragments on non-long bones including: patella and olecranon. Components in the Afghan External Fixator are for single use only.

Source page: https://510kreport.com/device/K092002
Methodology: https://510kreport.com/methodology