# K171568: SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty

- Pathway: 510(k) (Traditional)
- Applicant: Hans Biomed Corporation
- Decided: Feb 22, 2018 after 268 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: 3 generations back to K040980 (2004). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103784: DBX Demineralized Bone Matrix Putty, Musculoskeletal Transplant Foundation (2011) Summary page 4.
- K113728: Surfuse Gel and Putty, Exfuse Gel and Putty, Hans Biomed Corp. (2012) Summary page 4.

## Indications for use
SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, ExFuse™ Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bone structure. They are intended to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products resorb and are replaced with bone during the healing process.

Source page: https://510kreport.com/device/K171568
Methodology: https://510kreport.com/methodology