# K223075: Ogmend® Implant Enhancement System

- Pathway: 510(k) (Traditional)
- Applicant: Woven Orthopedic Technologies
- Decided: Feb 27, 2023 after 150 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
Longest line of descent: 1 generation back to DEN180065 (2020). 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)
- DEN180065: OGmend Implant System, Woven Orthopedic Technologies, LLC (2020) Summary page 5.

## 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/K223075
Methodology: https://510kreport.com/methodology