# K022908: Posterior Cable Screw

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Jan 22, 2004 after 506 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 1 generation back to K003351 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003351: Parsfix Cable-Screw System, Spinal Concepts, Inc. (2001) Summary page 1.

## Most influential descendants
- K151346: Frontier Medical Devices Posterior Cable Screw System (2015), 0 descendants of its own

## Indications for use
The Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolisthesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following: * Defect of the pars interarticularis * Spondylolithesis The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum. Cables and spinous process Grommets may be used for interspinous wiring if additional stability is needed.

Source page: https://510kreport.com/device/K022908
Methodology: https://510kreport.com/methodology