# K033951: Radix Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Pisharodi Surgicals, Inc.
- Decided: Jul 1, 2004 after 192 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: 1 generation back to K010003 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 1.
- K010003: Ebi Vuelock Anterior Cervical Plate System, Ebi, L.P. (2001)

## Most influential descendants
- K070335: Simplex Cervical Fixation System (2007), 0 descendants of its own

## Indications for use
Radix Cervical Plate 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

Source page: https://510kreport.com/device/K033951
Methodology: https://510kreport.com/methodology