# K143631: Benefix Interspinous Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corporation
- Decided: Sep 3, 2015 after 255 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: 7 generations back to K990745 (1999). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130438: Axle Interspinous Fusion System, X-Spine Systems, Inc. (2013) Summary page 4.
- K043053: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 4.
- K090252: Modification to: Lanx Spinal Fixation System, Lanx, Inc. (2009) Summary page 4.

## Indications for use
Benefix™ Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. Benefix™ Interspinous Fixation System is intended for use with bone graft material and is not intended for stand-alone use.

Source page: https://510kreport.com/device/K143631
Methodology: https://510kreport.com/methodology