# K242297: Reform Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Dec 17, 2024 after 137 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: 21 generations back to K040583 (2004). 549 ancestors in all.
No later device cites it as a predicate yet.
1 of 550 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200596: G21 Cement, VADER® Pedicle System, Icotec AG (2020) Summary page 6.
- K193011: CD Horizon™ Fenestrated Screw Set, Medtronic Sofamor Danek USA, Inc. (2020) Summary page 6.
- K150856: Reform Pedicle Screw System, Precision Spine, Inc. (2015) Summary page 5.

## 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 disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudarthrosis; 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. When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix ™ V and/or V-HP Gun with the G21 and Precision Spine Cement Cannula for mixing and injection of bone cements, the fenestrated Reform pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The fenestrated Reform pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Source page: https://510kreport.com/device/K242297
Methodology: https://510kreport.com/methodology