# K070335: Simplex Cervical Fixation System

- Pathway: 510(k) (Special)
- Applicant: Pisharodi Surgicals, Inc.
- Decided: Apr 16, 2007 after 70 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: 2 generations back to K010003 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033951: Radix Cervical Plate, Pisharodi Surgicals, Inc. (2004) Summary page 1.

## Indications for use
The SIMPLEX Cervical Fixation System is intended for anterior screw fixation of the cervical spine. Indications for use include: * 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 * deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) · tumor * pseudoarthrosis * failed previous fusion Warning: "This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine."

Source page: https://510kreport.com/device/K070335
Methodology: https://510kreport.com/methodology