# K121801: Quintex Cervical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Sep 11, 2012 after 84 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: 5 generations back to K922087 (1992). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100243: Quintex Cervical Plating System, Aesculap Implant Systems, LLC (2010) Summary page 1.

## Indications for use
The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability resulting from: *Degenerative disc disease (DOD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), *Spondylolisthesis, *Trauma (i.e. fracture or dislocation), *Spinal Stenosis, *Deformity (i.e., scoliosis, kyphosis, and/or lordosis), *Tumors, *Pseudoarthrosis as a result of failed spine surgery, *Failed previous fusions, *Symptomatic cervical spondylosis *Instability following surgery for the above indications. Levels of anterior cervical intervertebrall body screw fixation for this indication are from Cr-Ti. Warning: This device is not approved or intended for screw attachment of fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K121801
Methodology: https://510kreport.com/methodology