# K071879: Zimmer Dto Implant

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Spine, Inc.
- Decided: Oct 5, 2007 after 88 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: 4 generations back to K980288 (1998). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031511: Dynesys Spinal System, Centerpulse Spine-Tech, Inc. (2004) Summary page 2.
- K043565: Modification to Dynesys Spinal System, Zimmer Spine, Inc. (2005) Summary page 2.
- K060638: Dynesys Spinal System with HA Coated Screws, Zimmer Spine, Inc. (2006) Summary page 2.
- K020279: Forex Corporation, Optima, Spinal System, Forex Corp. (2002) Summary page 2.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 2.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 2.
- K051971: Optima Spinal System, U&I Corp. (2005) Summary page 2.

## Most influential descendants
- K101704: Zimmer Dto Pin Press Instrument (2010), 0 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0241-2013: 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 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® DTOTM 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/K071879
Methodology: https://510kreport.com/methodology