# K033512: Procyon Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Nas Medical Technologies, Inc.
- Decided: Jun 3, 2004 after 210 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: 2 generations back to K993030 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030285: Modification to TSRH Spinal System, Medtronic Sofamor Danek, Inc. (2003) Summary page 1.
- K021335: Monarch Spine System, Depuyacromed (2002) Summary page 1.

## Indications for use
When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients, the Procyon Spinal System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: 1) degenerative spondylolisthesis with objective evidence of neurological impairment, 2) fracture, 3) dislocation, 4) scoliosis, 5) kypohsis, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the Procyon Spinal System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autogenous bone graft only; 3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and 4) who are having the device removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K033512
Methodology: https://510kreport.com/methodology