# K173933: Sorrento Bioglass Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Xenco Medical, LLC
- Decided: Sep 13, 2018 after 261 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
Longest line of descent: 2 generations back to K032288 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141429: Sorrento Bone Graft Substitute, Haider Biologics, LLC (2015) Summary page 4.

## Indications for use
Sorrento Bone Graft Substitutes are intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitutes are also indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitutes must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitutes are resorbed and replaced with bone during the healing process

Source page: https://510kreport.com/device/K173933
Methodology: https://510kreport.com/methodology