# K191074: Sorrento Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Xenco Medical, LLC
- Decided: Sep 27, 2019 after 157 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: 8 generations back to K960978 (1996). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 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.
- K082166: Mastergraft Strip, Medtronic Sofamor Danek (2009) Summary page 5.

## Indications for use
Sorrento 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). Sorrento 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. Sorrento 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), Sorrento Bone Graft Substitutes are resorbed and replaced with bone during the healing process

Source page: https://510kreport.com/device/K191074
Methodology: https://510kreport.com/methodology