510(k) · Cleared
ClearedSurfuse Gel and Putty, Exfuse Gel and Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hans Biomed Corp. · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Nov 15, 2012 as substantially equivalent to K040419 (Isotis Orthobiologics, Inc., 2005) and 1 other predicate after a 332-day review. Its family tree reaches back 2 generations to 2004. 4 later devices descend from it.
- Decided
- Nov 15, 2012
- Review
- 332 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K040980 (2004). 4 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK040980 Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty…Wrightmedicaltechnologyinc · 2004
- 1 generation backK040419 Dynagraft IIIsotis Orthobiologics, Inc. · 2005
- This deviceK113728 Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp. · 2012
- Descendant · cites it directly · 0 of its ownK171568 SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse PuttyHans Biomed Corporation · 2018
- Descendant · cites it directly · 0 of its ownK152077 MaxiGenHans Biomed Corp. · 2016
- Descendant · cites it directly · 0 of its ownK151271 BellaFuseHans Biomed Corp. · 2016
- Descendant · cites it directly · 0 of its ownK130235 Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp. · 2014
Most influential descendants
Showing 4 of 4 · See all- K171568SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse PuttyHans Biomed Corporation · 2018 · cites it directly0descendants
- K152077MaxiGenHans Biomed Corp. · 2016 · cites it directly0descendants
- K151271BellaFuseHans Biomed Corp. · 2016 · cites it directly0descendants
- K130235Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040980 | Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite… | Wrightmedicaltechnologyinc | 2004 | — |
| −1 | K040419 | Dynagraft II | Isotis Orthobiologics, Inc. | 2005 | — |
| 0 (this device) | K113728 | Surfuse Gel and Putty, Exfuse Gel and Putty | Hans Biomed Corp. | 2012 | — |
| +1 | K171568 | SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty | Hans Biomed Corporation | 2018 | — |
| +1 | K152077 | MaxiGen | Hans Biomed Corp. | 2016 | — |
| +1 | K151271 | BellaFuse | Hans Biomed Corp. | 2016 | — |
| +1 | 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 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 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 MBP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBP device
- #1 K242799 PliaFX Floscore 9.0 · 3 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K040419 | Dynagraft IISummary page 1…Filler, bone void, calcium compound Filler, bone void, Osteoinduction (w/o Human Growth Factor) Device Class 11 Predicate Devices: K040419, Dynaraft 11Gel and Putty, IsoTis Ortholiologics, Inc. K05331 9, Allomatrix® Cusotm Putty, Wright Medical… | 2005 |
| * | K053319 | Allomatrix CustomSummary page 1…duction (w/o Human Growth Factor) Device Class 11 Predicate Devices: K040419, Dynaraft 11Gel and Putty, IsoTis Ortholiologics, Inc. K05331 9, Allomatrix® Cusotm Putty, Wright Medical Technology, Inc. Statement of The SurFuse It Gel, Sur… | 2006 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K171568 (Hans Biomed Corporation, 2018) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K040419.
How does its category compare?
All MBP devicesMBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MBP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MBP
181in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBP
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBP
2in 2025
MAUDE reports naming product code MBP, 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 | 5 | 188 | 0 | 7 |
| 2008 | 5 | 93 | 0 | 15 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 1 | — | 2 | 18 |
| 2012 | 1 | — | 13 | 24 |
| 2013 | 3 | 181 | 0 | 16 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 7 | 6 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113728: Surfuse Gel and Putty, Exfuse Gel and Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113728
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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