# K091725: Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549)

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corp.
- Decided: Nov 9, 2009 after 151 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: 3 generations back to K000319 (2000). 5 ancestors in all.
150 later devices descend from it; 4 cite it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 1.

## Most influential descendants
- K103085: Venus Basic Spinal Fixation System (2011), 123 descendants of its own
- K120270: Venus Spinal Fixation System (2012), 111 descendants of its own
- K123549: Polaris Spinal System - Ballista II Percutaneous Screw Placement System (2013), 75 descendants of its own
- K131615: Polaris Spinal System (2013), 70 descendants of its own
- K133746: Polaris Spinal System (2014), 67 descendants of its own

## Indications for use
The PerfixTM Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally- mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine: * Spondylolisthesis (Grade 3 and 4) * Degenerative spondylolisthesis with objective evidence of neurological impairment • Trauma (i.e., fracture or dislocation) * Spinal stenosis * Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) * Tumor * Pseudoarthrosis * Failed previous fusion

Source page: https://510kreport.com/device/K091725
Methodology: https://510kreport.com/methodology