# K143377: PedFuse Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Spinefrontier, Inc.
- Decided: Feb 12, 2015 after 79 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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: 10 generations back to K951116 (1995). 103 ancestors in all.
No later device cites it as a predicate yet.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133153: Spinefrontier Pedfuse Pedicle Screw System, Spinefrontier, Inc. (2014) Summary page 5.
- K123164: Spinefrontier Pedfuse Pedicle Screw System, Spinefrontier, Inc. (2013) Summary page 5.
- K092420: KRD1 Pedicle Screw System, Spinefrontier, Inc. (2009) Summary page 5.

## Indications for use
The SpineFrontier® PedFuse® 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 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 (Pseudarthrosis). In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (L3 to S1).

Source page: https://510kreport.com/device/K143377
Methodology: https://510kreport.com/methodology