# K151346: Frontier Medical Devices Posterior Cable Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Frontier Medical Devices, Inc.
- Decided: Aug 20, 2015 after 92 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003351 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022908: Posterior Cable Screw, Pioneer Surgical Technology (2004) Summary page 4.

## Indications for use
The Posterior Cable Screw System is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures as an adjunct to a rigid posterior fixation system cleared/approved for trauma and spondylolisthesis. The system is indicated for the following: • Defect of the pars interarticularis • Spondylolisthesis The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum. Cables may be used for interspinous wiring. The grommet may be used with the cable. The system is not intended to be used in conjunction with a stainless steel implant.

Source page: https://510kreport.com/device/K151346
Methodology: https://510kreport.com/methodology