# K132653: Neoplate Spine Anterior Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Neoortho Productos Orthopedicos S/A
- Decided: May 14, 2014 after 261 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K030327 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030327: Zephir Anterior Cervical System, Medtronic Sofamor Danek (2003) Summary page 1.

## Indications for use
The Nco~rtho NEOPLATE Spine Anterior Fixation System is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is incdicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by paitient history and radiographic studies), 2) trauma, (including fractures), 3) tumors. 4)deformity (defined by kyphosis, lordosis, or scoliosis), 5) pseudarilirosis, and/or 6) failed previous fusions. Note: this device system is intended for anterior cervical intervertebral body fusions only. Warning: This device is not approved lor screw attachment to the posterior elements (pedicles) of the cervical. thoracic or Ilmbar spine.

Source page: https://510kreport.com/device/K132653
Methodology: https://510kreport.com/methodology