# K160446: MCP Bone Putty

- Pathway: 510(k) (Traditional)
- Applicant: Biostructures, LLC
- Decided: Nov 7, 2016 after 264 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: 7 generations back to K960978 (1996). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 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.
- K142276: MCS Bone Graft, Biostructures, LLC (2015) Summary page 4.
- K071813: Mastergraft Putty, Medtronic Sofamor Danek (2007) Summary page 4.

## Most influential descendants
- K193513: SIGNAFUSE Bioactive Bone Graft (2020), 0 descendants of its own

## Indications for use
MCP Bone Putty is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCP Bone Putty is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCP Bone Putty is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K160446
Methodology: https://510kreport.com/methodology