# K160982: Sphynx™

- Pathway: 510(k) (Traditional)
- Applicant: Eden Spine, LLC
- Decided: Dec 22, 2016 after 259 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 K922543 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922543: Z-Plate Anterior Fixation System, Sofamor Danek Mfg., Inc. (1993) Summary page 5.
- K962784: Ultium Spinal Plating System, Smith & Nephew, Inc., Orthopaedic Div. (1996) Summary page 5.

## Indications for use
The antero-lateral plate Sphynx™ is designed for use during surgery on the thoraco-lumbar area of the spine (T1-L5). The device is to be used only on one side and placed in such a manner as to be as far away from blood vessels and nerve roots as possible. This implant is intended to provide stabilization until a solid spinal fusion develops, in the treatment of the following indications: - Tumor of the vertebral body - Fracture of the anterior spine (trauma) - Degenerative disc disease, compatible with a ventral approach (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) - Pseudoarthrosis - Spondylolysis - Spondylolisthesis - Scoliosis - Lordotic deformities of the spine - Spinal stenosis - Failed previous spine surgery

Source page: https://510kreport.com/device/K160982
Methodology: https://510kreport.com/methodology