# K120467: Spinal Elements Posterior Cervical/Thoracic Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Jul 30, 2012 after 166 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: 10 generations back to K853033 (1985). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052201: Solanas Posterior Stabilization System, Alphatec Spine, Inc. (2005) Summary page 2.
- K071380: Modification to Solanas Posterior Stabilization System, Alphatec Spine, Inc. (2007) Summary page 2.
- K002733: Summit Occipito-Cervico-Thoracic (Oct) Spinal System, Depuyacromed (2000) Summary page 2.
- K010681: Summit Occipito-Cervico-Thoracic (Oct) Spinal System, Depuyacromed (2001) Summary page 2.
- K062934: Sierra, Seaspine, Inc. (2006) Summary page 2.

## Most influential descendants
- K131427: LOTUS (2013), 0 descendants of its own

## Indications for use
The Spinal Elements Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (CI-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; tumors The use of polyaxial pedicle screws is limited to placement in T I -T3 for treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.

Source page: https://510kreport.com/device/K120467
Methodology: https://510kreport.com/methodology