# K243904: Elegance® Anterior Cervical plate

- Pathway: 510(k) (Special)
- Applicant: Clariance
- Decided: Jan 14, 2025 after 26 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: 5 generations back to K953730 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220182: Aggeris™-C, Clariance (2022) Summary page 5.

## Recalls of this device
- Feb 20, 2026 · Class II · Z-1821-2026: Due to a quality issue regarding the presence of burr on the finished cervical plate product.

## Indications for use
The Elegance® Anterior Cervical plate 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/K243904
Methodology: https://510kreport.com/methodology