# K023378: Oria Claris

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Tec, LLC
- Decided: Jun 27, 2003 after 262 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021679 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021679: Oria Spinal Clip System, Ortho Tec, LLC (2002). Cleared while this submission was under review

## Indications for use
MNH - When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients L3 & below who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-SI joint; receiving fusions using autogenous bone graft only; having the device fixed or attached to the lumbar and sacral spine; and having the device removed after the development of a solid fusion mass. MNI - 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 (T-10 - S1/2): degenerative spondylolisthesis with objective evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal tumor failed previous fusion (pseudarthrosis)

Source page: https://510kreport.com/device/K023378
Methodology: https://510kreport.com/methodology