# K162160: Preference Elite Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Amedica Corporation
- Decided: Nov 18, 2016 after 108 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: 11 generations back to K853033 (1985). 166 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081883: Modification to Preference Pedicle Screw System, Us Spine (2008) Summary page 4.
- K073430: Valeo Pedicle Screw Spinal System, Amedica Corp. (2008)

## Most influential descendants
- K212185: Golden Isles Pedicle Screw System (2021), 0 descendants of its own

## Indications for use
The Preference Elite Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine as follows: The Preference Elite System is intended for posterior, non-cervical pedicle and non-pedicle fixation in skeletally mature patients for the following indications: degenerative disc disease (DDD) (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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. In addition, when used as a pedicle screw fixation system, the Preference Elite Pedicle Screw System is indicated for skeletally matures patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint, (b) who are receiving fusions using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (d) who are having the device removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K162160
Methodology: https://510kreport.com/methodology