# K033965: Shiraz-Anterior System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Next America
- Decided: Mar 4, 2004 after 73 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K983583 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021880: Crossover Cross Connector (Moss Miami Spine System), Depuyacromed (2002) Summary page 1.

## Indications for use
When used as a pedicle screw fixation system, the SHIRAZ Systems are intended for treatment of severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone grafting having implaits attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. When used as a pedicle screw fixation system, the SHIRAZ Systems are also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). When used as a posterior, noncervical hook, and/or sacral/iliac screws fixation system, or as an bi-lateral anterior, thoracic/lumbar screw fixation system, the SHIRAZ Systems are intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., disogenic back pain with degeneration of the disc, confirmed by patient history and radiographic studies).

Source page: https://510kreport.com/device/K033965
Methodology: https://510kreport.com/methodology