# K111634: Xenon (TM) Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Jan 25, 2012 after 226 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: 9 generations back to K950697 (1995). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071890: Zodiac 4.0 Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2007) Summary page 2.
- K100685: Zodiac Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2010) Summary page 2.
- K110842: Atlas Spine Pedicle Screw System, Atlas Spine, Inc. (2011). Cleared while this submission was under review Summary page 2.

## Indications for use
The XENON Pedicle Screw System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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 lordosis); tumor; pseudarthrosis; and/or failed previous fusion. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft.

Source page: https://510kreport.com/device/K111634
Methodology: https://510kreport.com/methodology