# K023983: Modification to Highgate Curved Rod System

- Pathway: 510(k) (Special)
- Applicant: Highgate Orthopaedics
- Decided: Sep 22, 2003 after 294 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) Highgate Lateral Curved Rods: named in the summary without a submission number

## Indications for use
The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T6 to L5 in skeletally mature patients. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.

Source page: https://510kreport.com/device/K023983
Methodology: https://510kreport.com/methodology