# K133363: Interbridge Interspinous Posterior Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ldr Spine USA, Inc.
- Decided: Mar 7, 2014 after 126 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 K033826 (2004). 19 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100354: Primal OK Interspinous Fusion System, Osteomed LP (2010) Summary page 1.
- K073278: Spinous Process Plate System, Nuvasive, Inc. (2008) Summary page 1.
- K131238: Affix Spinous Process Plate System, Nuvasive, Inc. (2013) Summary page 1.
- K123093: Stabilink Mis Spinal Fixation System, Southern Spine, LLC (2012) Summary page 1.

## Most influential descendants
- K142378: Interspinous Plate System (2014), 3 descendants of its own
- K151863: Precision Spine Interspinous Plate System (2015), 2 descendants of its own
- K160465: Spinal Elements' Spinous Process Plate System (2016), 0 descendants of its own
- K160568: Precision Spine Interspinous Plate System (2016), 0 descendants of its own
- K142217: Reliance Interspinous Plate System (2015), 0 descendants of its own

## Indications for use
The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device intended for single-level use only in the non-cervical spine (TI-SI). It is intended for 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) * Spandylolisthesis * Trauma (fracture or dislocation) * Tumor The InterBRIDGE®D system is not intended for stand-alone use.

Source page: https://510kreport.com/device/K133363
Methodology: https://510kreport.com/methodology