# K133066: Spineselect Polyscrew Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Spineselect, LLC
- Decided: Jan 13, 2014 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: 4 generations back to K955348 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 2.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 2.
- K001319: Xia Spine System Hooks, Howmedica Osteonics Corp. (2000) Summary page 2.

## Indications for use
The SpineSelect Polyscrew Pedicle Screw System isintended for immobilization and stabilization of the spine. The SpineSelect Polyscrew Pedicle Screw System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft 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 lordlosis); tumor; pseudloarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K133066
Methodology: https://510kreport.com/methodology