# K081790: Modification to Single Planar Multi Axis (Spma) Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Trinity Orthopedics, LLC
- Decided: Jul 24, 2008 after 29 days
- Product code: MNI (Orthosis, Spinal Pedicle 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.
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) unmodified predicate SPMA Pedicle Screw System: named in the summary without a submission number

## Indications for use
Trinity SPMA Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K081790
Methodology: https://510kreport.com/methodology