# K060917: Kensey Nash Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corporation
- Decided: Sep 22, 2006 after 171 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: 6 generations back to K960978 (1996). 19 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040047: Polygraft BGS; Bone Graft Substitute, Osteobiologics, Inc. (2004) Summary page 1.
- K033707: Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX, Osteobiologics, Inc. (2004) Summary page 1.
- K033679: Copsios Bone Void Filler (BVF), Centerpulse Spine-Tech, Inc. (2004) Summary page 1.
- K051386: Mastergraft Putty Bone Void Filler, Medtronic Vascular (2005) Summary page 1.

## Most influential descendants
- K071187: Microfuse Bone Void Filler (2007), 4 descendants of its own
- K082442: Modification to Microfuse Bone Void Filler (2008), 2 descendants of its own
- K083232: Modification to:Microfuse Bone Void Filler (2008), 1 descendant of its own
- K120141: Kensey Nash Bone Void Filler XC (2012), 0 descendants of its own
- K102392: Microfuse Putty and Microfuse ST Mis (2010), 0 descendants of its own

## Indications for use
The Kensey Nash Bone Void Filler is intended to be gently packed into the bony voids or gaps of the extremities and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood or bone marrow aspirate. The addition of these autogenous products does not alter the performance of the device.

Source page: https://510kreport.com/device/K060917
Methodology: https://510kreport.com/methodology