# K200303: Reform Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine
- Decided: May 19, 2020 after 103 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). 398 ancestors in all.
10 later devices descend from it; 2 cite it directly.
1 of 409 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 4.
- K151422: Reform Pedicle Screw System, Precision Spine, Inc. (2015) Summary page 4.
- K122901: Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System, Orthofix (2012) Summary page 4.

## Most influential descendants
- K220862: E-GPS Navigated Instruments (2022), 7 descendants of its own
- K232044: Invictus Robotic Navigation Instruments (2023), 3 descendants of its own
- K240951: Invictus Robotic Navigation Instruments (2024), 2 descendants of its own
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own
- K242827: A8 INTEGR8™ Porous Pedicle Screws (2025), 1 descendant of its own

## Indications for use
The Reform Pedicle Screw System is intended for 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 disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion. The Reform Pedicle Screw System is to be used with autograft and/or allograft. When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Reform Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This 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/K200303
Methodology: https://510kreport.com/methodology