# K014107: Endius Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Endius, Inc.
- Decided: Feb 13, 2002 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Window Dynamic Plate System: named in the summary without a submission number
- (no number) Window Cervical Spinal System: named in the summary without a submission number

## Indications for use
The Endius Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and /or failed previous fusions. Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K014107
Methodology: https://510kreport.com/methodology