# K163363: SurgTech Thoracolumbosacral (TLS) Posterior Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Surgtech, Inc.
- Decided: Apr 5, 2017 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: 14 generations back to K040583 (2004). 86 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152457: CD HORIZON Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K092929: Synthes Matrix System, Synthes (Usa) (2009) Summary page 4.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 4.
- K051971: Optima Spinal System, U&I Corp. (2005) Summary page 4.

## Indications for use
The SurgTech Thoracolumbosacral (TLS) Posterior Fixation System is intended to provide pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: 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.

Source page: https://510kreport.com/device/K163363
Methodology: https://510kreport.com/methodology