# K102392: Microfuse Putty and Microfuse ST Mis

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Dec 22, 2010 after 121 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K960978 (1996). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071187: Microfuse Bone Void Filler, Globus Medical, Inc. (2007) Summary page 1.
- K082442: Modification to Microfuse Bone Void Filler, Globus Medical, Inc. (2008) Summary page 1.
- K083232: Modification to:Microfuse Bone Void Filler, Globus Medical, Inc. (2008) Summary page 1.

## Recalls of this device
- Aug 28, 2013 · Class II · Z-0123-2014: The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.

## Indications for use
MicroFuse® Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse® Bone Void Filler may be combined with autogenous bone marrow aspirate or autograft. MicroFuse® Putty is a bone graft extender to be used with autogenous bone marrow aspirate and autograft. MicroFuse® is intended to be gently packed into bony voids or gaps of the skeletal system (e.g. the spine, pelvis, and extremities). These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse® provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K102392
Methodology: https://510kreport.com/methodology