# K091110: Spinal Edge Titan Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Edge, LLC
- Decided: Jul 24, 2009 after 98 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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: 4 generations back to K944736 (1995). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 1.
- K024348: Monarch Spine System, Depuyacromed (2003) Summary page 1.
- K023438: Modification to Monarch Spine System, Depuyacromed (2002) Summary page 1.
- K021335: Monarch Spine System, Depuyacromed (2002) Summary page 1.

## Most influential descendants
- K122814: Galleon Pedicle Screw System (2012), 0 descendants of its own

## Indications for use
The Spinal Edge TITAN Pedicle Screw Systems is intended for posterior, noncervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - SI.

Source page: https://510kreport.com/device/K091110
Methodology: https://510kreport.com/methodology