# K201029: Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Jun 17, 2020 after 58 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: 6 generations back to K953730 (1995). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101848: Sapphire Anterior Cervical Plate System, Spinal Elements, Inc. (2010) Summary page 5.
- K133518: Maxan Anterior Cervical Plate System, Biomet Spine (Aka Ebi, LLC) (2014) Summary page 7.

## Most influential descendants
- K231593: Sapphire X3 Anterior Cervical Plate System (2023), 0 descendants of its own

## Indications for use
The Sapphire® Spinal 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 The Sapphire X Anterior Cervical Plate Spinal 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/K201029
Methodology: https://510kreport.com/methodology