# K142276: MCS Bone Graft

- Pathway: 510(k) (Traditional)
- Applicant: Biostructures, LLC
- Decided: Jan 16, 2015 after 154 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: 5 generations back to K990131 (1999). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 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.
- K051774: MBCP, Biomatlante (2006) Summary page 4.

## Most influential descendants
- K160446: MCP Bone Putty (2016), 1 descendant of its own
- K193513: SIGNAFUSE Bioactive Bone Graft (2020), 0 descendants of its own
- K162860: MCS Bone Graft (2017), 0 descendants of its own

## Indications for use
MCS Bone Graft is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MCS Bone Graft is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities and pelvis) and is used mixed with bone marrow aspirate. Once implanted, the device resorbs and is replaced with host bone during the healing process.

Source page: https://510kreport.com/device/K142276
Methodology: https://510kreport.com/methodology