# K094002: Spartek Variable Angle Pedicle Screw Posterior Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Spartek Medical, Inc.
- Decided: May 7, 2010 after 130 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K103383: Spartek Variable Angle Pedicle Screw Posterior Fusion System (2011), 0 descendants of its own

## Indications for use
The SpartekTM Variable Angle Pedicle Screw Posterior Fusion System is intended for immobilization and stabilization of the thoracic, lumbar, and sacral spine in skeletally mature patients as an adjunct to fusion with autogenous bone graft for the following indications: 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K094002
Methodology: https://510kreport.com/methodology