# K220182: Aggeris™-C

- Pathway: 510(k) (Traditional)
- Applicant: Clariance
- Decided: Mar 30, 2022 after 68 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: 4 generations back to K953730 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103491: Skyline Anterior Cervical Plate System, A Johnson & Johnson Company (2011) Summary page 4.

## Most influential descendants
- K243904: Elegance® Anterior Cervical plate (2025), 0 descendants of its own

## Indications for use
The Aggeris™-C device is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include: 1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies) 2. Spondylolisthesis 3. Spinal stenosis 4. Deformities (i.e., scoliosis, kyphosis, and/or lordosis) 5. Pseudoarthrosis 6. Revision of previous surgery

Source page: https://510kreport.com/device/K220182
Methodology: https://510kreport.com/methodology