# K082504: Apollo Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Spine, Inc.
- Decided: Jan 27, 2009 after 151 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 K926453 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926453: Synthes (U.S.a.) Anterior Cervical Vertebrae Plate, Synthes (Usa) (1993) Summary page 1.

## Most influential descendants
- K090751: Comet Anterior Cervical Plate System (2009), 0 descendants of its own

## Indications for use
The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation for the following indications: degenerative disc disease, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K082504
Methodology: https://510kreport.com/methodology