# K180655: Viking Lumbar Polyaxial Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Presidio Surgical
- Decided: Jul 13, 2018 after 122 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: 8 generations back to K950697 (1995). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120091: R&D Innovation Pedicle Screw System, R&D Innovation, LLC (2012) Summary page 5.
- K120832: Fortex Pedicle Screw System, X-Spine Systems, Inc. (2012) Summary page 5.
- K111940: S 100 Pedicle Screw System, Renovis Surgical Technologies, LLC (2012) Summary page 5.

## Indications for use
When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the Presidio Surgical Viking Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).

Source page: https://510kreport.com/device/K180655
Methodology: https://510kreport.com/methodology