# K173130: Reform® Midline Cortical Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Dec 19, 2017 after 81 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: 19 generations back to K003155 (2001). 406 ancestors in all.
21 later devices descend from it; 3 cite it directly.
1 of 428 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150856: Reform Pedicle Screw System, Precision Spine, Inc. (2015) Summary page 6.
- K171082: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System, Orthofix, Inc. (2017) Summary page 6.

## Most influential descendants
- K220862: E-GPS Navigated Instruments (2022), 7 descendants of its own
- K193396: PERLA® TL posterior osteosynthesis system (2020), 7 descendants of its own
- K210539: CoreLink Midline Fixation System (2021), 4 descendants of its own
- K203222: PERLA TL Posterior Osteosynthesis System (2020), 4 descendants of its own
- K232044: Invictus Robotic Navigation Instruments (2023), 3 descendants of its own

## Indications for use
The Reform® Midline Cortical Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Source page: https://510kreport.com/device/K173130
Methodology: https://510kreport.com/methodology