# K091219: Del Mar Monoaxial Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Allez Spine, LLC
- Decided: Jul 9, 2009 after 73 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) LAGUNA® Monoaxial Pedicle Screw System: named in the summary without a submission number

## Most influential descendants
- K110679: Del Mar Monoaxial Pedicle Screw System (2011), 0 descendants of its own

## Indications for use
The DEL MAR® Monoaxial Pedicle Screw System is intended for posterior, non-cervical fixation for the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion. The DEL MAR® Monoaxial Pedicle Screw System is intended to be used with autograft and/or allograft as an adjunct to fusion.

Source page: https://510kreport.com/device/K091219
Methodology: https://510kreport.com/methodology