# K073347: Dynesys Top-Loading Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Feb 8, 2008 after 71 days
- Product code: NQP (Posterior Metal/Polymer Spinal System, Fusion)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dynesys® Spinal System: named in the summary without a submission number
- (no number) Medtronic Sofamor Danek CD HORIZON Spinal System: named in the summary without a submission number

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0242-2013: 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 
- May 28, 2009 · Not classified · Z-0370-2010: The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay.

## 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 (pseudoarthrosis). 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. When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO implant, rod-cord combination implant, and the U&I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

Source page: https://510kreport.com/device/K073347
Methodology: https://510kreport.com/methodology