# K153302: coflex-IF

- Pathway: 510(k) (Traditional)
- Applicant: Paradigm Spine, LLC
- Decided: Sep 8, 2016 after 300 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: 5 generations back to K032037 (2003). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112595: Coflex-F, Paradigm Spine, LLC (2012) Summary page 4.
- K093438: Paradigm Interspinous Fusion Plate, Paradigm Spine, LLC (2010) Summary page 4.
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007) Summary page 4.
- K073278: Spinous Process Plate System, Nuvasive, Inc. (2008) Summary page 4.

## Most influential descendants
- K232484: KeyLift™ Expandable Interlaminar Stabilization System (2023), 0 descendants of its own
- K201704: CoFix System (2020), 0 descendants of its own

## Indications for use
The coflex-IF 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/K153302
Methodology: https://510kreport.com/methodology