# K242899: NOVA Minimally Invasive System

- Pathway: 510(k) (Special)
- Applicant: Baui Biotech Co., Ltd.
- Decided: Oct 17, 2024 after 24 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: 18 generations back to K040583 (2004). 229 ancestors in all.
No later device cites it as a predicate yet.
0 of 230 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182416: NOVA Minimally Invasive System, Baui Biotech Co., Ltd. (2019) Summary page 5.

## Indications for use
The NOVA Minimally Invasive System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (defined as discogenic back pain 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, and . Failed previous fusion

Source page: https://510kreport.com/device/K242899
Methodology: https://510kreport.com/methodology