# K091944: Modification to: DSS Stabilization System

- Pathway: 510(k) (Special)
- Applicant: Paradigm Spine, LLC
- Decided: Aug 3, 2009 after 34 days
- Product code: NQP (Posterior Metal/Polymer Spinal System, Fusion)
- 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: 5 generations back to K901587 (1990). 26 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072969: DSS, Paradigm Spine, LLC (2008) Summary page 2.
- K080963: DSS Stabilization System, Paradigm Spine (2008) Summary page 2.
- K080241: DDS Stabilization System, Paradigm Spine, LLC (2008) Summary page 2.
- K090408: Modification to: DSS Stabilization System, Paradigm Spine, LLC (2009) Summary page 2.
- K090099: DSS Stabilization System, Paradigm Spine, LLC (2009) Summary page 2.

## Most influential descendants
- K101083: DSS Stabilization System (2010), 2 descendants of its own
- K113625: DSS Stabilization System (2012), 1 descendant of its own
- K120491: DSS Stabilization System-Rigid (2012), 0 descendants of its own

## Indications for use
DSSTM Stabilization System - Rigid The DSSTM Stabilization System - Rigid is intended as a single-level system for noncervical pedicle fixation from the T4 to S1 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. 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/K091944
Methodology: https://510kreport.com/methodology