# K051959: NV Cormed Solas Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Nv Cormed
- Decided: Oct 12, 2005 after 86 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K083178: Solas Anatomix Spinal System (2009), 0 descendants of its own

## Indications for use
The CORMED NV, SOLAS™, Spinal System is a pedicle screw based spinal fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra 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. In addition, the SOLAS is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion and 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the SOLAS is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

Source page: https://510kreport.com/device/K051959
Methodology: https://510kreport.com/methodology