# K122777: NBX - Non Bridging External Fixator Hand

- Pathway: 510(k) (Traditional)
- Applicant: Nutek Orthopaedics, Inc.
- Decided: May 15, 2013 after 246 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 K033476 (2004). 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)
- K051605: Sbi K-Wires, Small Bone Innovations, LLC (2005) Summary page 1.
- K033476: Modification to Hoffmann II Micro External Fixation System, Howmedica Osteonics Corp. (2004) Summary page 1.

## Indications for use
The NBX® Non-Bridging External Fixator - Hand, is used for definitive external fixation, until healing. This device is used for the fixation of open or closed fractures, mal-union, and non-union of the metacarpals and phalanges of the hand.

Source page: https://510kreport.com/device/K122777
Methodology: https://510kreport.com/methodology