510(k) · Cleared
ClearedAllomatrix Custom
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · MQV Filler, Bone Void, Calcium Compound
Cleared on Mar 6, 2006 after a 96-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Mar 6, 2006
- Review
- 96 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK053319 Allomatrix CustomWrightmedicaltechnologyinc · 2006
- Descendant · cites it directly · 4 of its ownK113728 Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp. · 2012
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK151271 BellaFuseHans Biomed Corp. · 2016
- Descendant · 2 generations on · 0 of its ownK130235 Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp. · 2014
Most influential descendants
Showing 5 of 5 · See all- K113728Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp. · 2012 · cites it directly4descendants
- K171568SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse PuttyHans Biomed Corporation · 2018 · 2 generations on0descendants
- K152077MaxiGenHans Biomed Corp. · 2016 · cites it directly0descendants
- K151271BellaFuseHans Biomed Corp. · 2016 · 2 generations on0descendants
- K130235Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053319 | Allomatrix Custom | Wrightmedicaltechnologyinc | 2006 | — |
| +1 | K113728 | Surfuse Gel and Putty, Exfuse Gel and Putty | Hans Biomed Corp. | 2012 | — |
| +2 | K171568 | SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty | Hans Biomed Corporation | 2018 | — |
| +1 | K152077 | MaxiGen | Hans Biomed Corp. | 2016 | — |
| +2 | K151271 | BellaFuse | Hans Biomed Corp. | 2016 | — |
| +2 | K130235 | Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty | Hans Biomed Corp. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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 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? (1)
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 |
|---|---|---|---|
| * | — | autologous iliac crest bone Named without a submission number |
What descends from it? (5)
2 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?
- Of its descendants, K113728 (Hans Biomed Corp., 2012) has gone furthest, with 4 descendants of its own.
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.
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?
ALLOMATRIX ® Custom is indicated only for bony voids or gaps that are not intrinsic to the stability of bony structure. ALLOMATRIX® Custom is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine), and 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053319: Allomatrix Custom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053319
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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