# K073214: Duowedge Synthetic Bone Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Kasios
- Decided: Dec 1, 2009 after 748 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- 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 no predicate by number.

## Indications for use
When used with appropriate opening osteotomy system devices, plates and screws, Duowedge is intended to be used as a bone void filler in tibial osteotomies. Duowedge is to be used in combination with adequate post-operative immobilization.

Source page: https://510kreport.com/device/K073214
Methodology: https://510kreport.com/methodology