# K151770: Libra Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Balance, Inc.
- Decided: Nov 20, 2015 after 143 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: 16 generations back to K853033 (1985). 290 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 292 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133369: Tiger Spine System, Corelink, LLC (2014) Summary page 5.
- K143569: CD HORIZON Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 5.
- K101144: Modification to:Radius Spinal System, Stryker Spine (2010) Summary page 5.
- K120074: Foundation Spinal System, The Skeletal Design Partnership, Ltd. (2012) Summary page 5.

## Most influential descendants
- K162750: Libra Pedicle Screw System (2016), 0 descendants of its own

## Indications for use
The Libra Pedicle Screw System is intended for immobilization and stabilization of the posterior thoracic, lumbar and sacral/iliac spine (Tl-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/K151770
Methodology: https://510kreport.com/methodology