# K160320: Premier

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Weigao Orthopaedic Device Co., Ltd.
- Decided: Apr 1, 2016 after 56 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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: 7 generations back to K950697 (1995). 45 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113666: Xia 3 Spinal System, Stryker Spine (2012) Summary page 6.

## Most influential descendants
- K170861: Premier (2017), 0 descendants of its own

## Indications for use
The Premier is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft.

Source page: https://510kreport.com/device/K160320
Methodology: https://510kreport.com/methodology