# K142217: Reliance Interspinous Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Reliance Medical Systems, LLC
- Decided: Apr 2, 2015 after 233 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: 8 generations back to K033826 (2004). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133363: Interbridge Interspinous Posterior Fixation System, Ldr Spine USA, Inc. (2014) Summary page 5.
- K073278: Spinous Process Plate System, Nuvasive, Inc. (2008) Summary page 5.
- K131238: Affix Spinous Process Plate System, Nuvasive, Inc. (2013) Summary page 5.
- K123093: Stabilink Mis Spinal Fixation System, Southern Spine, LLC (2012) Summary page 5.
- K100354: Primal OK Interspinous Fusion System, Osteomed LP (2010) Summary page 5.
- K122509: Vertiflex Spinous Process Fixation Plate, Vertiflex, Inc. (2012) Summary page 5.

## Indications for use
The Reliance Interspinous Plate System is a supplemental fixation device intended as an adjunct to fusion of the thoracolumbar (T1-S1) spine by fixation to the spinous processes in skeletally mature patients, and is indicated for the following: - degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - spondylolisthesis - trauma (i.e., fracture or dislocation) - tumors This device is not intended for stand-alone use.

Source page: https://510kreport.com/device/K142217
Methodology: https://510kreport.com/methodology