# K252542: LEO Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: ZheJiang Decans Medical Devices Co., Ltd.
- Decided: Apr 29, 2026 after 260 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 31 generations back to K841189 (1984). 838 ancestors in all.
No later device cites it as a predicate yet.
1 of 839 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113666: Xia 3 Spinal System, Stryker Spine (2012) Summary page 5.
- K223494: CD Horizon Spinal System, Medtronic (2023) Summary page 5.

## Indications for use
The LEO Spinal System is intended for use in the noncervical spine. When used as a posterior, noncervical pedicle and non-pedicle fixation system, the LEO Spinal System is intended as an adjunct to fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (i.e. fracture or dislocation), Spinal stenosis, Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), Tumor, Pseudoarthrosis, Failed previous fusion.

Source page: https://510kreport.com/device/K252542
Methodology: https://510kreport.com/methodology