# K192049: Oryx Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Nov 8, 2019 after 100 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K031276 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 4.
- K061147: Opteryx Anterior Cervical Plate System, Innovasis, Inc. (2006) Summary page 4.

## Recalls of this device
- Apr 7, 2020 · Class II · Z-2062-2020: Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location labeled as "Fixed" should be labeled as "Variable" and the caddy location labeled

## Indications for use
The Innovasis Oryx Cervical Plate System is intended for use in anterior cervical fixation for the following indications: i. Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), ii. Spondylolisthesis, iii. Trauma (i.e., fracture or dislocation) iv. Spinal stenosis, v. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), vi. Tumor, vii. Pseudoarthrosis; and viii. Previous failed fusion. The Innovasis Oryx Cervical Plate System is indicated for stabilizing the cervical spine from C2 to C7.

Source page: https://510kreport.com/device/K192049
Methodology: https://510kreport.com/methodology