# K120491: DSS Stabilization System-Rigid

- Pathway: 510(k) (Traditional)
- Applicant: Paradigm Spine, LLC
- Decided: May 9, 2012 after 82 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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 K901587 (1990). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042962: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.
- K080241: DDS Stabilization System, Paradigm Spine, LLC (2008) Summary page 2.
- K090099: DSS Stabilization System, Paradigm Spine, LLC (2009) Summary page 2.
- K090408: Modification to: DSS Stabilization System, Paradigm Spine, LLC (2009) Summary page 2.
- K101083: DSS Stabilization System, Paradigm Spine, LLC (2010) Summary page 2.
- K113625: DSS Stabilization System, Paradigm Spine, LLC (2012) Summary page 2.

## Indications for use
DSSTM Stabilization System - Rigid The DSSTM Stabilization System - Rigid is intended for noncervical pedicle fixation from the T4 to SI vertebrae in skeletally mature patients to help provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following indications: 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSSTM Stabilization System - Rigid is intended to be used with autograft and/or allograft. Note: The Rigid Couplers are for single-level use only. The traditional straight rods are for single- and multi-level use. DSSTM Stabilization System - Slotted The DSSTM Stabilization System - Slotted is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudarthrosis). In addition, the DSSTM Stabilization System - Slotted is indicated for use in patients: * Who are receiving fusions with autogenous graft only; * Who are having the device fixed or attached to the lumbar or sacral spine; * Who are having the device removed after the development of a solid fusion mass. Note: The Rigid Coupler and Slotted Coupler are not intended to be used together.

Source page: https://510kreport.com/device/K120491
Methodology: https://510kreport.com/methodology