# K141429: Sorrento Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Haider Biologics, LLC
- Decided: Feb 23, 2015 after 269 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: 1 generation back to K032288 (2003). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032288: Vitoss Scaffold Foam Bone Graft Material, Orthovita, Inc. (2003) Summary page 4.

## Most influential descendants
- K191074: Sorrento Bone Graft Substitute (2019), 0 descendants of its own
- K173933: Sorrento Bioglass Bone Graft Substitute (2018), 0 descendants of its own

## 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 in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitute is resorbed and replaced with bone during the healing process.

Source page: https://510kreport.com/device/K141429
Methodology: https://510kreport.com/methodology