# K223563: OsteoCNX

- Pathway: 510(k) (Traditional)
- Applicant: Converg Engineering
- Decided: Jan 25, 2023 after 57 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
OsteoCNX Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (extremities, pelvis, posterior lateral spine). OsteoCNX Bone Graft Substitute is also indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. OsteoCNX Bone Graft Substitute must be wetted with bone marrow aspirate or, when used in the posterolateral spine, autologous bone must also be added (50/50 ratio by volume). Following placement in the bony void or gap (defect), OsteoCNX Bone Graft Substitutes are resorbed and replaced with bone during the healing process

Source page: https://510kreport.com/device/K223563
Methodology: https://510kreport.com/methodology