# K060491: Quantum Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Quantum Orthopedics, Inc.
- Decided: Mar 13, 2006 after 17 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K101848: Sapphire Anterior Cervical Plate System (2010), 2 descendants of its own
- 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 Quantum 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, deformaties or curvatures (kyphosis, lordosis, or scoliosis), tumors, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K060491
Methodology: https://510kreport.com/methodology