# K112595: Coflex-F

- Pathway: 510(k) (Traditional)
- Applicant: Paradigm Spine, LLC
- Decided: Feb 13, 2012 after 159 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- 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: 4 generations back to K032037 (2003). 7 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093438: Paradigm Interspinous Fusion Plate, Paradigm Spine, LLC (2010) Summary page 2.

## Most influential descendants
- K153302: coflex-IF (2016), 2 descendants of its own
- K232484: KeyLift™ Expandable Interlaminar Stabilization System (2023), 0 descendants of its own
- K201704: CoFix System (2020), 0 descendants of its own
- K160568: Precision Spine Interspinous Plate System (2016), 0 descendants of its own

## Indications for use
The coflex-F Implant 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 (Li-Si). 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/K112595
Methodology: https://510kreport.com/methodology