# K021919: SCS Claris Spinal System,Rextended Omniaxial Connector-,Medium, Model CO05, SCS Claris Spinal System,Extended Omniaxialo

- Pathway: 510(k) (Special)
- Applicant: Ortho Tec, LLC
- Decided: Jul 3, 2002 after 22 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. The FDA summary names its predicate without a number.
- (no number) SCS OmniAxial Connector (C004): named in the summary without a submission number

## Indications for use
When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; fracture; spinal stenosis; deformities (i.e., scoliosis, kyphosis, lordosis); tumors; failed previous fusion (pseudarthrosis). When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; fracture; spinal stenosis; deformities (i.e., scoliosis, kyphosis, lordosis); tumors; failed previous fusion (pseudarthrosis). When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; receiving fusions using autogenous bone graft only; having the device fixed or attached to the lumbar and sacral spine; having the device removed after the development of a solid fusion mass. Screw fixation is limited to L3 and below. Posterior pedicle systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K021919
Methodology: https://510kreport.com/methodology