# K152548: AXI+LINE Proximal Bunion Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Nextremity Solutions, Inc.
- Decided: Dec 21, 2015 after 104 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: 12 generations back to K962616 (1996). 178 ancestors in all.
No later device cites it as a predicate yet.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131061: Restore Bunion Correction System, Nextremity Solutions (2013) Summary page 4.
- K140724: MSP Metatarsal Shortening System, Nextremity Solutions, Inc. (2014) Summary page 4.
- K143365: Eminent Foot Plate System, Eminent Spine (2015) Summary page 4.
- K142581: APTUS Foot System, Medartis AG (2015) Summary page 4.

## Indications for use
The AXI+LINE™ Proximal Bunion Correction System is indicated for fixation of fractures, osteotomies, non-unions and fusions of small bones and small bone segments in the foot and ankle.

Source page: https://510kreport.com/device/K152548
Methodology: https://510kreport.com/methodology