# K993926: Omniaxial Connector

- Pathway: 510(k) (Special)
- Applicant: Ortho Tec, LLC
- Decided: Dec 17, 1999 after 29 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: 5 generations back to K901587 (1990). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983353: SCS Spinal System, Orthotec, Inc. (1998) Summary page 1.

## 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 pseudarthrosis 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 pseudarthrosis failed previous fusion (pseudarthrosis) 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-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. 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/K993926
Methodology: https://510kreport.com/methodology