# K061147: Opteryx Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasis, Inc.
- Decided: Jun 30, 2006 after 66 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: 3 generations back to K031276 (2003). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K050451: Synthes Vectra System, Synthes Spine Co.Lp (2005) Summary page 1.
- K994239: Zephir Anterior Cervical Plate System, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.

## Most influential descendants
- K192049: Oryx Cervical Plate System (2019), 0 descendants of its own

## Recalls of this device
- May 5, 2017 · Class II · Z-2153-2017: Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).

## Indications for use
The Innovasis Opteryx TM Cervical Plate System is intended for use in anterior cervical fixation for the following indications: Degenerative Disc Disease (DDD) (defined as neck 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, and/or Previous failed fusion. The Innovasis Opteryx TM Anterior Cervical Plate System is indicated for stabilizing the cervical spine from C2 to C7.

Source page: https://510kreport.com/device/K061147
Methodology: https://510kreport.com/methodology