# K093438: Paradigm Interspinous Fusion Plate

- Pathway: 510(k) (Traditional)
- Applicant: Paradigm Spine, LLC
- Decided: Oct 6, 2010 after 336 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K032037 (2003). 6 ancestors in all.
5 later devices descend from it; 3 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)
- K032037: CD Horizon (Addition of Spinous Process Plate), Medtronic Sofamor Danek (2003) Summary page 1.
- K071877: Lanx Spinal Fixation System, Lanx, LLC (2007)
- K073278: Spinous Process Plate System, Nuvasive, Inc. (2008) Summary page 1.

## Most influential descendants
- K112595: Coflex-F (2012), 4 descendants of its own
- 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

## Recalls of this device
- Aug 28, 2012 · Class II · Z-0412-2013: Inspan Compressors may break at weld causing a loss of compression

## Indications for use
The Paradigm Interspinous Fusion Plate 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 I spondylolisthesis.

Source page: https://510kreport.com/device/K093438
Methodology: https://510kreport.com/methodology