# K151362: HC Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Hung Chun Bio-S Co., Ltd.
- Decided: May 5, 2016 after 350 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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 K950697 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050461: Xia 4.5 Spinal System, Stryker Spine (2005) Summary page 4.

## Indications for use
The HC Spinal System is intended for posterior noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients for the following indications: severe spondylolisthesis (i.e., Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Source page: https://510kreport.com/device/K151362
Methodology: https://510kreport.com/methodology