# K113728: Surfuse Gel and Putty, Exfuse Gel and Putty

- Pathway: 510(k) (Traditional)
- Applicant: Hans Biomed Corp.
- Decided: Nov 15, 2012 after 332 days
- Product code: MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor))
- 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: 2 generations back to K040980 (2004). 4 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040419: Dynagraft II, Isotis Orthobiologics, Inc. (2005) Summary page 1.
- K053319: Allomatrix Custom, Wrightmedicaltechnologyinc (2006) Summary page 1.

## Most influential descendants
- K171568: SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty (2018), 0 descendants of its own
- K152077: MaxiGen (2016), 0 descendants of its own
- K151271: BellaFuse (2016), 0 descendants of its own
- K130235: Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty (2014), 0 descendants of its own

## Indications for use
The SurFusem Gel, Surusem Putty, ExpuseM Gel, and ExFusewr Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Source page: https://510kreport.com/device/K113728
Methodology: https://510kreport.com/methodology