# K080241: DDS Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Paradigm Spine, LLC
- Decided: Nov 28, 2008 after 302 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: 3 generations back to K901587 (1990). 21 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962628: Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 2.
- K973836: Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System, Cross Medical Products, Inc. (1998) Summary page 2.
- K052123: Synthes Pangea System, Synthes (Usa) (2005) Summary page 2.
- K993067: Silhouette Spinal Fixation System, Sulzer Spine-Tech (1999) Summary page 2.

## Most influential descendants
- K090408: Modification to: DSS Stabilization System (2009), 4 descendants of its own
- 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 DSS Stabilization System - Rigid is intended as a single-level system 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 DSS Stabilization System - Rigid is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K080241
Methodology: https://510kreport.com/methodology