# DEN180065: OGmend Implant System

- Pathway: De Novo (Direct)
- Applicant: Woven Orthopedic Technologies, LLC
- Decided: May 1, 2020 after 505 days
- Product code: QAC (Screw Sleeve Bone Fixation Device)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K223075: Ogmend® Implant Enhancement System (2023), 0 descendants of its own

## Indications for use
The OGmend® Implant System is for the use with screws as part of a fracture fixation plate system in long bones in rescue scenarios where the screw has lost purchase due to screw loosening, back out, or breakage and the stability of the plate construct is at risk. The OGmend® Implant System is for use in skeletally mature patients.

Source page: https://510kreport.com/device/DEN180065
Methodology: https://510kreport.com/methodology