# K043565: Modification to Dynesys Spinal System

- Pathway: 510(k) (Special)
- Applicant: Zimmer Spine, Inc.
- Decided: Mar 11, 2005 after 74 days
- Product code: NQP (Posterior Metal/Polymer Spinal System, Fusion)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K980288 (1998). 2 ancestors in all.
834 later devices descend from it; 3 cite it directly.
1 of 837 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031511: Dynesys Spinal System, Centerpulse Spine-Tech, Inc. (2004)

## Most influential descendants
- K060615: CD Horizon Spinal System (2006), 822 descendants of its own
- K063670: Modifications to CD Horizon Spinal System (2007), 821 descendants of its own
- K082236: CD Horizon Spinal System (2008), 779 descendants of its own
- K091442: CD Horizon Spinal System (2009), 776 descendants of its own
- K091974: Modification to CD Horizon Spinal System (2009), 656 descendants of its own

## Recalls of this device
- 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 

## 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, 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: * 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/K043565
Methodology: https://510kreport.com/methodology