# K101848: Sapphire Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Elements, Inc.
- Decided: Oct 14, 2010 after 105 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: 3 generations back to K792352 (1979). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060491: Quantum Anterior Cervical Plate System, Quantum Orthopedics, Inc. (2006) Summary page 2.
- K926453: Synthes (U.S.a.) Anterior Cervical Vertebrae Plate, Synthes (Usa) (1993) Summary page 2.
- K100265: Diamond Anterior Cervical Plate System, Amendia, Inc. (2010) Summary page 2.
- K042499: Orion Anterior Cervical Plating System, Medtronic Sofamor Danek (2004) Summary page 2.

## Most influential descendants
- K201029: Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System (2020), 1 descendant of its own
- K231593: Sapphire X3 Anterior Cervical Plate System (2023), 0 descendants of its own

## Indications for use
The Sapphire Anterior Cervical Plate System is intended for anterior cervical fixation (C2 - C7) 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, lordlosis or scoliosis), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K101848
Methodology: https://510kreport.com/methodology