# K230067: Para-Fix External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: New Paradigm Biomedical
- Decided: Sep 22, 2023 after 256 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- 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: 2 generations back to K051306 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051306: Hoffmann II Mri External Fixation System, Howmedica Osteonics Corp. (2005)
- K111786: Hoffmann 3 Modular External Fixation System, Stryker Corp. (2012) Summary page 4.

## Indications for use
The Para-Fix External Fixation System is intended to provide stabilization of open and/or unstable fractures and where tissue injury precludes the use of other fracture treatments such as IM rodding or casting. The specific indications for the Para-Fix External Fixation System include: * Bone fracture fixation * Osteotomy * Arthrodesis * Correction of deformity * Revision procedure where other treatments or devices have been unsuccessful * Bone reconstruction procedures

Source page: https://510kreport.com/device/K230067
Methodology: https://510kreport.com/methodology