# K082833: NBX - Non-Bridging External Fixator - Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Nutek Orthopaedics, Inc.
- Decided: Feb 5, 2009 after 132 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 K052605 (2005). 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)
- K070561: Kmedic Internal/External Fixation Devices, Teleflex Medical (2007) Summary page 1.
- K052605: External Fixation, Gexfix USA, Inc. (2005) Summary page 1.

## Indications for use
The NBXTM Non-Bridging External Fixator - Shoulder, is used for external fixation, until healing. This device is used for the fixation of open or closed fractures, mal-union, and non-union of the proximal end of the humerus to include sub-capital and/or fractures of the humeral head.

Source page: https://510kreport.com/device/K082833
Methodology: https://510kreport.com/methodology