# K083826: Laguna Polyaxial Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Allez Spine, LLC
- Decided: Jan 22, 2009 after 30 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
No predicates in its family tree.
18 later devices descend from it; 2 cite it directly.
0 of 19 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 Polyaxial Pedicle Screw System: named in the summary without a submission number

## Most influential descendants
- K103748: Laguna Pedicle Screw System (2011), 15 descendants of its own
- K122332: Towerlox Pedicle Screw System (2012), 14 descendants of its own
- K131538: Caplox II Pedicle Screw System/Towerlox Pedicle Screw System (2013), 6 descendants of its own
- K152781: Adena-Zina System (2016), 5 descendants of its own
- K212066: Adena-Zina System (2021), 3 descendants of its own

## Indications for use
The LAGUNA® Polyaxial 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

Source page: https://510kreport.com/device/K083826
Methodology: https://510kreport.com/methodology