# K121172: Reform Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Spinal USA
- Decided: Aug 8, 2012 after 113 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: 13 generations back to K853033 (1985). 96 ancestors in all.
33 later devices descend from it; 5 cite it directly.
0 of 130 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.
- K073240: PSS System, Spinal USA (2008) Summary page 1.
- K090033: Modification to: PSS System, Spinal USA (2009) Summary page 1.
- K092128: Modification to: PSS System, Spinal USA (2009) Summary page 1.
- K061520: Viper Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K111571: Viper Systems, Johnson & Johnson (2011) Summary page 1.

## Cited in the summary but kept off the family tree
- K090228: Roc Lumbar Plating System, Alphatec Spine, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K173130: Reform® Midline Cortical Screw System (2017), 21 descendants of its own

## Indications for use
The ReForm Pedicle Screw 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 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/K121172
Methodology: https://510kreport.com/methodology