# K201704: CoFix System

- Pathway: 510(k) (Special)
- Applicant: Paradigm Spine GmbH
- Decided: Aug 4, 2020 after 43 days
- Product code: PEK (Spinous Process Plate)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K032037 (2003). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153302: coflex-IF, Paradigm Spine, LLC (2016) Summary page 4.

## Indications for use
The CoFix System is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease — defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies — with up to Grade 1 spondylolisthesis.

Source page: https://510kreport.com/device/K201704
Methodology: https://510kreport.com/methodology