# K171582: NEO Pedicle Screw System™

- Pathway: 510(k) (Traditional)
- Applicant: Neo Medical SA
- Decided: Sep 12, 2017 after 104 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: 15 generations back to K853033 (1985). 91 ancestors in all.
No later device cites it as a predicate yet.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112453: Sterispineps Pedicle Screw, Safe Orthopaedics (2011) Summary page 4.
- K111136: Expedium Spine System, Viper System, Viper 2 System, Depuy Spine, Inc. (2012) Summary page 4.
- K131802: Expedium, Viper. Viper 2 Spine System, Depuy Spine, A Johnson & Johnson Company (2013) Summary page 4.
- K143200: MIS Z-Pedicle Screw System, Z-Medical GmbH & Co. KG (2015) Summary page 4.

## Indications for use
The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation 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, tumor, pseudarthrosis, and/or failed previous fusion.

Source page: https://510kreport.com/device/K171582
Methodology: https://510kreport.com/methodology