# K100970: Stainless Steel Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Theken Spine, LLC
- Decided: Aug 12, 2010 after 126 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). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041592: Coral Spinal System, Theken Surgical (2004) Summary page 1.
- K070962: Coral Pedicle Screw System, Theken Spine, LLC (2007) Summary page 1.
- K081414: Modification to Coral Spinal System, Theken Spine, LLC (2008) Summary page 1.
- K053276: Ist Pedicle Screw System, Innovative Spinal Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K120829: Stainless Steel Spinal System (2012), 0 descendants of its own

## Indications for use
The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (TI-S2/ilium), a posterior non-pedicle screw fixation system (TI -L5), or as an anterolateral fixation system (T8-L,5). 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/K100970
Methodology: https://510kreport.com/methodology