# K073240: PSS System

- Pathway: 510(k) (Special)
- Applicant: Spinal USA
- Decided: Mar 20, 2008 after 125 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 4 generations back to K000319 (2000). 8 ancestors in all.
36 later devices descend from it; 8 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071438: PSS System, Spinal USA (2007) Summary page 1.

## Most influential descendants
- K121172: Reform Pedicle Screw System (2012), 33 descendants of its own
- K131343: Reform Pedicle Screw System (2013), 31 descendants of its own
- K130279: Reform Pedicle Screw System (2013), 31 descendants of its own
- K143248: Reform Pedicle Screw System (2014), 30 descendants of its own
- K150856: Reform Pedicle Screw System (2015), 26 descendants of its own

## Indications for use
The PSS System is 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, and failed previous fusion (pseudoarthrosis). The PSS System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S I 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. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K073240
Methodology: https://510kreport.com/methodology