# K182416: NOVA Minimally Invasive System

- Pathway: 510(k) (Abbreviated)
- Applicant: Baui Biotech Co., Ltd.
- Decided: Jun 11, 2019 after 280 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: 17 generations back to K040583 (2004). 228 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171082: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System, Orthofix, Inc. (2017) Summary page 4.

## Most influential descendants
- K251251: ChanPin Pedicle Screw Spinal System (2026), 0 descendants of its own
- K242899: NOVA Minimally Invasive System (2024), 0 descendants of its own

## 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), 2. Spondylolisthesis, 3. Trauma (i.e., fracture or dislocation) 4. Spinal stenosis, 5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), 6. Tumor, 7. Pseudoarthrosis, and 8. Failed previouis fusion

Source page: https://510kreport.com/device/K182416
Methodology: https://510kreport.com/methodology