# K162750: Libra Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Spinal Balance, Inc.
- Decided: Oct 27, 2016 after 27 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 K853033 (1985). 291 ancestors in all.
No later device cites it as a predicate yet.
0 of 292 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151770: Libra Pedicle Screw System, Spinal Balance, Inc. (2015) Summary page 5.

## Indications for use
The Libra Pedicle Screw System is intended for immobilization and stabilization of the posterior thoracic, lumbar and sacral/iliac spine (T1-S1/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Source page: https://510kreport.com/device/K162750
Methodology: https://510kreport.com/methodology