# K173185: SEURAT™ Universal Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Ctl Medical Corporation
- Decided: Feb 14, 2018 after 138 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: 12 generations back to K990745 (1999). 145 ancestors in all.
No later device cites it as a predicate yet.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132365: Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation, Accel Spine (2013) Summary page 5.
- K120714: Picasso Mis Spinal Fixation System, Accel Spine (2012) Summary page 5.
- K121568: Dali Spinal Fixation System, Accel Spine (2012) Summary page 5.
- K140219: Picasso II Mis Spinal System, Accel Spine (2014) Summary page 5.

## Indications for use
The SEURAT™ Universal Pedicle Screw System is intended to provide immobilization and stabilization of the spinal segments, (T1 – S2/ilium) or as an anterolateral fixation system (T8 – L5), in skeletally mature patients as an adjunct to fusion. The SEURAT™ Universal Pedicle Screw System is a posterior, non-cervical, pedicle system indicated for 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, pseudarthosis; and failed previous fusion. The SEURAT™ Universal Pedicle Screw System can be used in an open approach and percutaneous approach with MIS instrumentation.

Source page: https://510kreport.com/device/K173185
Methodology: https://510kreport.com/methodology