# K120829: Stainless Steel Spinal System

- Pathway: 510(k) (Special)
- Applicant: Theken Spine, LLC
- Decided: May 30, 2012 after 72 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: 5 generations back to K955348 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100970: Stainless Steel Spinal System, Theken Spine, LLC (2010) Summary page 1.

## Indications for use
The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedlicle screw fixation system (TI-52/ilium), a posterior non-pedicle screw fixation system (Tl-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K120829
Methodology: https://510kreport.com/methodology