# K080963: DSS Stabilization System

- Pathway: 510(k) (Special)
- Applicant: Paradigm Spine
- Decided: May 2, 2008 after 28 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K091944: Modification to: DSS Stabilization System (2009), 3 descendants of its own
- 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
The DSSTM Stabilization System 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 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.

Source page: https://510kreport.com/device/K080963
Methodology: https://510kreport.com/methodology