# K233223: OGmend® Implant Enhancement System

- Pathway: 510(k) (Special)
- Applicant: Woven Orthopedic Technologies
- Decided: Oct 26, 2023 after 28 days
- Product code: QVI (Screw Sleeve Bone Fixation Device, Spine)
- Device class: 2
- Regulation: 21 CFR 888.3043
- 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K190519: Ogmend® Implant Enhancement System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Ogmend® Implant Enhancement System is intended to augment pedicle screw fixation when a screw has lost purchase due to screw loosening, back-out, or breakage. The Ogmend® Implant Enhancement System is for use with rigid, thoracolumbar pedicle screw systems where a screw is inserted posteriorly, through the pedicle, and into the vertebral body. The Ogmend® Implant Enhancement System is for use in skeletally mature patients.

Source page: https://510kreport.com/device/K233223
Methodology: https://510kreport.com/methodology