510(k) · Cleared
ClearedBellaFuse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hans Biomed Corp. · MQV Filler, Bone Void, Calcium Compound
Cleared on Mar 11, 2016 as substantially equivalent to K043421 (Regeneration Technologies, Inc., 2005) and 2 other predicates after a 303-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Mar 11, 2016
- Review
- 303 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K040980 (2004). 8 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 deviceK151271 BellaFuseHans Biomed Corp. · 2016
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) | K151271 | BellaFuse | Hans Biomed Corp. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K043421 | Opteform, Osteofil, Rti Allograft Paste IC, Rti Allograft Strip ICSummary page 4…ame: Classification Number: 21 CFR 888.3045 Product Code: MQV, MBP Device Class: II Predicate Devices: Primary: K043421, RTI Allograft Strip IC, Regeneration Technologies, Inc. K06220… | 2005 |
| * | K062205 | DBX StripSummary page 4…Predicate Devices: Primary: K043421, RTI Allograft Strip IC, Regeneration Technologies, Inc. K062205, DBX® Strip, Musculoskeletal Transplant Foundation K113728, SurFuse™ Gel & Putty, ExFuse™ Gel & P… | 2007 |
| * | K113728 | Surfuse Gel and Putty, Exfuse Gel and PuttySummary page 4…Technologies, Inc. K062205, DBX® Strip, Musculoskeletal Transplant Foundation K113728, SurFuse™ Gel & Putty, ExFuse™ Gel & Putty, Hans Biomed Corp. Indications for Use… | 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 12 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K043421.
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. 2016, 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?
BellaFuse™ is an implant intended to fill bony voids or gaps of the skeletal system i.e., posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. BellaFuse™ resorbs and is 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/K151271 · printed Nov 5, 2026
Cite this page
510(k) Report. “K151271: BellaFuse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151271
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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