# K143248: Reform Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Dec 19, 2014 after 37 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 17 generations back to K003155 (2001). 349 ancestors in all.
30 later devices descend from it; 3 cite it directly.
1 of 380 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131343: Reform Pedicle Screw System, Spinal USA (2013) Summary page 5.
- K130279: Reform Pedicle Screw System, Spinal USA (2013) Summary page 5.
- K121172: Reform Pedicle Screw System, Spinal USA (2012) Summary page 5.
- K092128: Modification to: PSS System, Spinal USA (2009) Summary page 5.
- K090033: Modification to: PSS System, Spinal USA (2009) Summary page 5.
- K073240: PSS System, Spinal USA (2008) Summary page 5.
- K071438: PSS System, Spinal USA (2007) Summary page 5.
- K133746: Polaris Spinal System, Biomet Spine (Aka Ebi, LLC) (2014) Summary page 6.
- K131615: Polaris Spinal System, Biomet Spine (Aka Ebi, LLC) (2013) Summary page 6.

## Most influential descendants
- 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
- K172101: ROMEO® 2 Posterior Osteosynthesis System (2017), 9 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of 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. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K143248
Methodology: https://510kreport.com/methodology