# K130235: Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty

- Pathway: 510(k) (Traditional)
- Applicant: Hans Biomed Corp.
- Decided: Jan 10, 2014 after 345 days
- Product code: NUN (Bone Grafting Material, Human Source)
- Device class: 2
- Regulation: 21 CFR 872.3930
- 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113728: Surfuse Gel and Putty, Exfuse Gel and Putty, Hans Biomed Corp. (2012) Summary page 1.
- K051188: Grafton DBM, Osteotech, Inc. (2006) Summary page 1.
- K091217: DBX Demineralized Bone Matrix Putty, Musculoskeletal Transplant Foundation (2009) Summary page 1.

## Indications for use
The SurFusenhII Putty and ExFuseTm 1 Putty are bone filling materials indicated for dental intraosseous, oral and maxillofacial defects, including periodontal/infrabony defects: alveolar ridge augmentation: dental extraction sites: sinus lifts: cystic defects.

Source page: https://510kreport.com/device/K130235
Methodology: https://510kreport.com/methodology