# K231593: Sapphire X3 Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Aug 2, 2023 after 62 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: 7 generations back to K971730 (1997). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152455: Amendia Cervical Plate System, Amendia, Inc. (2015) Summary page 5.
- K201029: Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System, Spinal Elements, Inc. (2020) Summary page 5.

## Indications for use
The Sapphire X3 Anterior Cervical Plate System is intended for anterior cervical fixation (C2-T1) in skeletally mature patients as an adjunct to fusion for the following indications: • Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) • Spondylolisthesis • Trauma (including fracture or dislocation) • Spinal stenosis • Deformities or Curvatures (kyphosis, lordosis or scoliosis) • Tumor • Pseudoarthrosis • Failed previous fusion

Source page: https://510kreport.com/device/K231593
Methodology: https://510kreport.com/methodology