510(k) · Cleared
ClearedInterface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biostructures · MQV Filler, Bone Void, Calcium Compound
Cleared on Nov 9, 2010 as substantially equivalent to K021336 (Novabone Products, LLC, 2002) after a 447-day review. Its family tree reaches back 3 generations to 1996. 9 later devices descend from it.
- Decided
- Nov 9, 2010
- Review
- 447 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960978 (1996). 4 ancestors in all. 9 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 2 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 1 generation backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- This deviceK092541 InterfaceBiostructures · 2010
- Descendant · cites it directly · 8 of its ownK112857 Interface Bone Void FillerBiostructures, LLC · 2011
- Descendant · 2 generations on · 6 of its ownK132071 Bioactive Bone Graft PuttyBiostructures, LLC · 2014 · Recalled
- Descendant · 3 generations on · 4 of its ownK171563 MagnetOs PuttyKuros Biosciences B.V · 2017
- Descendant · 4 generations on · 3 of its ownK211201 MagnetOs Easypack PuttyKuros Biosciences B.V · 2021
- Descendant · 5 generations on · 2 of its ownK233607 MagnetOs Easypack PuttyKuros Biosciences B.V · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K112857Interface Bone Void FillerBiostructures, LLC · 2011 · cites it directly8descendants
- K132071Bioactive Bone Graft PuttyBiostructures, LLC · 2014 · 2 generations on6descendants
- K171563MagnetOs PuttyKuros Biosciences B.V · 2017 · 3 generations on4descendants
- K211201MagnetOs Easypack PuttyKuros Biosciences B.V · 2021 · 4 generations on3descendants
- K233607MagnetOs Easypack PuttyKuros Biosciences B.V · 2023 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −2 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −1 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| 0 (this device) | K092541 | Interface | Biostructures | 2010 | — |
| +1 | K112857 | Interface Bone Void Filler | Biostructures, LLC | 2011 | — |
| +2 | K132071 | Bioactive Bone Graft Putty | Biostructures, LLC | 2014 | 1 |
| +3 | K171563 | MagnetOs Putty | Kuros Biosciences B.V | 2017 | — |
| +4 | K211201 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2021 | — |
| +5 | K233607 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K021336 | Novabone-Resorbable Bone Graft SubstituteSummary page 2…Bone Void Filler is substantially equivalent in indications and design principles to NovaBone Resorbable Bone Graft Substitute from NovaBone Products, LLC, cleared under K02 1336. The subject device and the predicate device have the same intended use and have the same technological characteristics. The sub… | 2002 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112857 | Interface Bone Void Filler | 2011 | 8 |
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 3.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K112857 (Biostructures, LLC, 2011) has gone furthest, with 8 descendants of its own.
- 12 other devices also cite its predicate K021336.
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. 2010, 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?
Interface Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. Interface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092541: Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092541
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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