# K130279: Reform Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal USA
- Decided: Jun 20, 2013 after 135 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: 14 generations back to K853033 (1985). 130 ancestors in all.
31 later devices descend from it; 3 cite it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121172: Reform Pedicle Screw System, Spinal USA (2012) Summary page 1.
- K092128: Modification to: PSS System, Spinal USA (2009) Summary page 1.
- K090033: Modification to: PSS System, Spinal USA (2009) Summary page 1.
- K073240: PSS System, Spinal USA (2008) Summary page 1.
- K071438: PSS System, Spinal USA (2007) Summary page 1.
- K091067: 5.5 Polaris Spinal System, Biomet Spine (2009) Summary page 1.

## Most influential descendants
- K143248: Reform Pedicle Screw System (2014), 30 descendants of its own
- K150856: Reform Pedicle Screw System (2015), 26 descendants of its own
- K173130: Reform® Midline Cortical Screw System (2017), 21 descendants of its own
- K151422: Reform Pedicle Screw System (2015), 19 descendants of its own
- K200303: Reform Pedicle Screw System (2020), 10 descendants of its own

## Indications for use
The ReForm Pedicle Screw System is intended to provide immobilization and stabilization of spinal scgments in skeletally maturc patients as an adjunct to fusion in the trecatment of the following acute and chronic instabilities or deformitics of thoracic, Jumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment. fracture. dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pscudarthrosis). The ReForm Pedicle Screw Svstem is also intended for non-cervical pedicle screw fixation for the lollowing indications: severe spondylolisthesis (grades 3und 4of the 1.5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants afier the attainment of a solid [usion. It is also intended {or the following indications: trauma (i.c. fracture or dislocation); spinal stenosis; curvatures (i.c. scoliosis. kKyphosis; and/or lordosis) spinal tumor; pseudloarthrosis; and failed previous fusion.

Source page: https://510kreport.com/device/K130279
Methodology: https://510kreport.com/methodology