# K133153: Spinefrontier Pedfuse Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Spinefrontier, Inc.
- Decided: May 14, 2014 after 209 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: 9 generations back to K951116 (1995). 102 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123164: Spinefrontier Pedfuse Pedicle Screw System, Spinefrontier, Inc. (2013) Summary page 1.
- K092420: KRD1 Pedicle Screw System, Spinefrontier, Inc. (2009) Summary page 1.
- K091797: TSRH Spinal System, Medtronic Sofamor Danek (2010) Summary page 1.
- K101790: Quantum Spinal System, Quantum Mis, Pioneer Surgical Technology (2011) Summary page 1.
- K073439: Transition Stabilization System, Globus Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K143377: PedFuse Pedicle Screw System (2015), 0 descendants of its own

## Indications for use
The SpineFrontier®V Ped~uset 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 spandylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogenous bane graft, with the device fixed or attached to the lumbar and sacral spine. When used in a percutaneous approach with MIS instrumentation, the SpineFrontier®&Ped~use®9 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, failed previous fusion (Pseitidarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-SlI vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.

Source page: https://510kreport.com/device/K133153
Methodology: https://510kreport.com/methodology