# K170108: Xultan 5.5 Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Met One Technologies
- Decided: May 2, 2017 after 110 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: 8 generations back to K950697 (1995). 27 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000236: Synergy VLS Cap Nut Models 2206, 6102, Interpore Cross Intl. (2000) Summary page 5.
- K111940: S 100 Pedicle Screw System, Renovis Surgical Technologies, LLC (2012) Summary page 5.

## Most influential descendants
- K250866: Sovereign Posterior Cervical System (2025), 1 descendant of its own
- K254260: The VEGA Cervical Screw System (2026), 0 descendants of its own

## Indications for use
The Xultan 5.5 Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The Xultan 5.5 Pedicle Screw System is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine (T1-S2/ilium); 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; curvature (i.e., scoliosis, kyphosis and/or lordosis); tumor; and failed previous fusion (i.e., pseudoarthrosis).

Source page: https://510kreport.com/device/K170108
Methodology: https://510kreport.com/methodology