510(k) · Cleared
ClearedSurfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hans Biomed Corp. · NUN Bone Grafting Material, Human Source
Cleared on Jan 10, 2014 as substantially equivalent to K113728 (Hans Biomed Corp., 2012) and 2 other predicates after a 345-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Jan 10, 2014
- Review
- 345 days
- Class
- Class II
- Product code
- NUN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K040980 (2004). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK040980 Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty…Wrightmedicaltechnologyinc · 2004
- 2 generations backK040419 Dynagraft IIIsotis Orthobiologics, Inc. · 2005
- 1 generation backK113728 Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp. · 2012
- This deviceK130235 Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040980 | Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite… | Wrightmedicaltechnologyinc | 2004 | — |
| −2 | K040419 | Dynagraft II | Isotis Orthobiologics, Inc. | 2005 | — |
| −1 | K113728 | Surfuse Gel and Putty, Exfuse Gel and Putty | Hans Biomed Corp. | 2012 | — |
| 0 (this device) | K130235 | Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty | Hans Biomed Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113728 | Surfuse Gel and Putty, Exfuse Gel and PuttySummary page 1…21 CFR 872.3930 Number: Product Code and NUN Classification Name Bone grafting material, human source Device Class 11 Predicate Devices: K113728, Surpusem' Putty, ExFusem' Putty, HansBiomed Corp K051188, GRAFTONOI DBM, Osle… | 2012 |
| * | K051188 | Grafton DBMSummary page 1…n source Device Class 11 Predicate Devices: K113728, Surpusem' Putty, ExFusem' Putty, HansBiomed Corp K051188, GRAFTONOI DBM, Osleotech, Inc. K091217, DBX Demineralized bone matrix putty,… | 2006 |
| * | K091217 | DBX Demineralized Bone Matrix PuttySummary page 1…3728, Surpusem' Putty, ExFusem' Putty, HansBiomed Corp K051188, GRAFTONOI DBM, Osleotech, Inc. K091217, DBX Demineralized bone matrix putty, Musculoskeletal Transplant Foundation. Indications for Use:… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K113728.
How does its category compare?
All NUN devicesNUN Bone Grafting Material, Human Source: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NUN
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NUN
75in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUN
No recall names NUN since 2007.
Adverse event reports per year · NUN
6in 2025
MAUDE reports naming product code NUN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 4 | 75 | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 25 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130235: Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130235
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026