# K031511: Dynesys Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Centerpulse Spine-Tech, Inc.
- Decided: Mar 5, 2004 after 296 days
- Product code: NQP (Posterior Metal/Polymer Spinal System, Fusion)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K980288 (1998). 1 ancestor in all.
902 later devices descend from it; 8 cite it directly.
1 of 904 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980288: Spine-Tech Silhouette Spinal Fixation System, Spine-Tech, Inc. (1998) Summary page 1.

## Most influential descendants
- K050809: CD Horizon Spinal System (2005), 870 descendants of its own
- K043565: Modification to Dynesys Spinal System (2005), 834 descendants of its own
- K060615: CD Horizon Spinal System (2006), 822 descendants of its own
- K063670: Modifications to CD Horizon Spinal System (2007), 821 descendants of its own
- K052187: Modification to:  CD Horizon Spinal System (2005), 780 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0236-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 
- Sep 4, 2012 · Class II · Z-0237-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 
- Sep 4, 2012 · Class II · Z-0239-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 
- Sep 4, 2012 · Class II · Z-0238-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 

## Indications for use
When used as a pedicle screw fixation system in skeletally mature patients, the DYNESYS Spinal 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, when used as a pedicle screw fixation system, the DYNESYS Spinal System is indicated for use in patients: a) Who are receiving fusions with autogenous graft only b) Who are having the device fixed or attached to the lumbar or sacral spine; and c) Who are having the device removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K031511
Methodology: https://510kreport.com/methodology