# K132218: Perfix Iliac Screw System

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corporation
- Decided: Dec 17, 2013 after 153 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011437: Synergy 4.0 MM, 4.5 MM VLS Screws, Interpore Cross Intl. (2001) Summary page 1.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 1.
- K001668: Global Spinal Fixation System, D.K.M. Co., Ltd. (2000) Summary page 1.

## Indications for use
The Perfix™ 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 * Spinal deformities (Scoliosis, Kyphosis, Lordosis) * Pelvic obliquity * Spinal tumor * Pseudarthrosis * Failed previous fusion The Perfix™ Iliac Screw System includes the following four components; iliac screw, iliac connector, iliac cap, and a set screw. These components are only to be used in conjunction with the Perfix™ Spinal System's 6.0mm diameter rods.

Source page: https://510kreport.com/device/K132218
Methodology: https://510kreport.com/methodology