# K061162: Bar Pedicle Screw Spinal Fixation System, Model 2020

- Pathway: 510(k) (Traditional)
- Applicant: Applied Spine Technologies, Inc.
- Decided: Jul 26, 2006 after 91 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: 5 generations back to K901587 (1990). 35 ancestors in all.
131 later devices descend from it; 1 cites it directly.
0 of 167 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031511: Dynesys Spinal System, Centerpulse Spine-Tech, Inc. (2004) Summary page 1.
- K990118: Isobar Spinal System, Scien'Tx USA, Inc. (1999) Summary page 1.
- K043488: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 1.

## Most influential descendants
- K092624: Firebird Spinal Fixation System (2009), 130 descendants of its own
- K100044: Firebird Spinal Fixation System, Firebird Side-Loading Body (2010), 117 descendants of its own
- K122901: Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System (2012), 116 descendants of its own
- K093926: Firebird Spinal Fixation System (2010), 88 descendants of its own
- K130932: Firebird Spinal Fixation System (2013), 81 descendants of its own

## Indications for use
The BAR Pedicle Screw Spinal Fixation System is intended for posterior non cervical pedicle screw fixation in the lumbo-sacral spine 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 lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). In addition the BAR Pedicle Screw Spinal Fixation System, used as a pedicle screw fixation system is intended for: a. Patients receiving only autogenous bone graft. b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-Sl) vertebral joint.

Source page: https://510kreport.com/device/K061162
Methodology: https://510kreport.com/methodology