510(k) · Cleared
ClearedSurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hans Biomed Corporation · MQV Filler, Bone Void, Calcium Compound
Cleared on Feb 22, 2018 as substantially equivalent to K103784 (Musculoskeletal Transplant Foundation, 2011) and 1 other predicate after a 268-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Feb 22, 2018
- Review
- 268 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K040980 (2004). 7 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 deviceK171568 SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse PuttyHans Biomed Corporation · 2018
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) | K171568 | SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty | Hans Biomed Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 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 MQV? 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 MQV device
- #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K103784 | DBX Demineralized Bone Matrix PuttySummary page 4…Product Code: MQV, MBP Classification Name: Filler, bone void, calcium compound Device Class: II Predicate Devices: Primary: K103784, DBXŠ Demineralized Bone Matrix Putty, Musculoskeletal Transplant Foundation… | 2011 |
| * | K113728 | Surfuse Gel and Putty, Exfuse Gel and PuttySummary page 4…imary: K103784, DBXŠ Demineralized Bone Matrix Putty, Musculoskeletal Transplant Foundation Reference: K113728, SurFuseTM Gel, SurFuseTM Putty, ExFuse™ Gel, ExFuseTM Putty, Hans Biomed Corp. Statem… | 2012 |
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 14 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 4 other devices also cite its predicate K103784.
How does its category compare?
All MQV devicesMQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MQV
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQV
57in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQV
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQV
57in 2025
MAUDE reports naming product code MQV, 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 | 35 | 144 | 5 | 67 |
| 2008 | 32 | 102 | 3 | 71 |
| 2009 | 23 | 180 | 1 | 81 |
| 2010 | 17 | 147 | 0 | 68 |
| 2011 | 16 | 92 | 6 | 114 |
| 2012 | 9 | 107 | 3 | 149 |
| 2013 | 12 | 197 | 2 | 223 |
| 2014 | 20 | 153 | 0 | 111 |
| 2015 | 18 | 184 | 0 | 125 |
| 2016 | 8 | 214 | 1 | 106 |
| 2017 | 17 | 124 | 1 | 107 |
| 2018 | 23 | 124 | 2 | 86 |
| 2019 | 13 | 90 | 0 | 65 |
| 2020 | 15 | 132 | 1 | 126 |
| 2021 | 8 | 88 | 0 | 101 |
| 2022 | 9 | 118 | 0 | 47 |
| 2023 | 21 | 74 | 3 | 120 |
| 2024 | 28 | 55 | 2 | 68 |
| 2025 | 14 | 57 | 1 | 57 |
| 2026 | 5 | 96 | 4 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171568: SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171568
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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