# K990986: Contour Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Oct 14, 1999 after 204 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
When used as a pedicle screw fixation system (MNH) The Contour™ Spinal System is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion mass. Use of a hook, rod, and ileo-sacral screw fixation system (KWP) T1-S1, the Lumbar Hopk Sacral Screw Construct of the Contour™ Spinal System, will assist in arthrodesis or fusion of the thoracic, lumbar and lumbosacral spine. The indications for use are: Spondylolisthesis; Fracture; Spinal Stenosis; Deformities (scoliosis, kyphosis, lordosis); Pseudarthrosis Tumor Revision of previously failed fusion surgery The hooks are to be used for fixation to include the first thoracic vertebra down to the sacrum. The pedicle screws are used for sacral fixation only.

Source page: https://510kreport.com/device/K990986
Methodology: https://510kreport.com/methodology