# K161798: FacetBRIDGE® System

- Pathway: 510(k) (Special)
- Applicant: Ldr Spine USA, Inc.
- Decided: Aug 4, 2016 after 35 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K953076 (1997). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152137: FacetBRIDGE System, Ldr Spine USA (2016) Summary page 4.

## Indications for use
The FacetBRIDGE® System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. This system is intended for use only with bone graft material. This system is not to be used with bone cement. The FacetBRIDGE® System is indicated for treatment for any or all of the following: • Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity, • Spondylolisthesis, • Spondylolysis, • Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, • Degeneration of the facets with instability, • Trauma including spinal fractures and/or dislocations.

Source page: https://510kreport.com/device/K161798
Methodology: https://510kreport.com/methodology