# K260291: Vortex5 Tailor's Bunion Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, Inc.
- Decided: Mar 25, 2026 after 55 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 14 generations back to K962616 (1996). 231 ancestors in all.
No later device cites it as a predicate yet.
0 of 232 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202657: Javelin Tailor's Bunion Fixation System, Nvision Biomedical Technologies, Inc. (2020) Summary page 5.
- K182949: Healix™ Compression Screw System, Nvision Biomedical Technologies, LLC (2018) Summary page 5.
- K171558: ExsoMed ITN Cannulated Screw System, Exsomed Holdings Company, LLC (2017)

## Indications for use
The Vortex5 Tailor's Bunion Correction System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the toes (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent patients (13-21 years of age).

Source page: https://510kreport.com/device/K260291
Methodology: https://510kreport.com/methodology