# K103383: Spartek Variable Angle Pedicle Screw Posterior Fusion System

- Pathway: 510(k) (Special)
- Applicant: Spartek Medical, Inc.
- Decided: Feb 17, 2011 after 91 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: 1 generation back to K094002 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094002: Spartek Variable Angle Pedicle Screw Posterior Fusion System, Spartek Medical, Inc. (2010). Our reading of the summary gave K094402, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SpartekTM Variable Angle Pedicle Screw Posterior Fusion System”.

## 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 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/K103383
Methodology: https://510kreport.com/methodology