# K051697: Selective-Axis Posterior Noncervical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Advisory Development Group
- Decided: Sep 21, 2005 after 90 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.
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) EBI's SpineLink-II Spinal Fixation System: named in the summary without a submission number
- (no number) Scient'x Aladyn Rigid Spine Plate: named in the summary without a submission number

## Indications for use
The Selective-Axis Posterior Noncervical Plating System is intended for use as a posterior, noncervical (thoracic, lumbar and sacral) pedicle screw fixation system for the following indications: degenerative disc disease ("DDD") (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, tumor, pseudoarthrosis, and failed fusion.

Source page: https://510kreport.com/device/K051697
Methodology: https://510kreport.com/methodology