# K170861: Premier

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Weigao Orthopaedic Device Co., Ltd.
- Decided: Aug 4, 2017 after 134 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: 18 generations back to K003155 (2001). 345 ancestors in all.
No later device cites it as a predicate yet.
1 of 346 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160320: Premier, Shandong Weigao Orthopaedic Device Co., Ltd. (2016) Summary page 4.
- K101070: Expedium Spine System, Medos International SARL (2010) Summary page 4.
- K150896: Vitality Spinal Fixation System, Zimmer Spine, Inc. (2015) Summary page 4.

## Indications for use
The Premier is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1): 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, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K170861
Methodology: https://510kreport.com/methodology