510(k) · Cleared
ClearedInterface Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biostructures, LLC · MQV Filler, Bone Void, Calcium Compound
Cleared on Dec 13, 2011 as substantially equivalent to K092541 (Biostructures, 2010) and 1 other predicate after a 74-day review. Its family tree reaches back 4 generations to 1996. 8 later devices descend from it.
- Decided
- Dec 13, 2011
- Review
- 74 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K960978 (1996). 5 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 3 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 2 generations backK021336 Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC · 2002
- 1 generation backK092541 InterfaceBiostructures · 2010
- This deviceK112857 Interface Bone Void FillerBiostructures, LLC · 2011
- Descendant · cites it directly · 6 of its ownK132071 Bioactive Bone Graft PuttyBiostructures, LLC · 2014 · Recalled
- Descendant · 2 generations on · 4 of its ownK171563 MagnetOs PuttyKuros Biosciences B.V · 2017
- Descendant · 3 generations on · 3 of its ownK211201 MagnetOs Easypack PuttyKuros Biosciences B.V · 2021
- Descendant · 4 generations on · 2 of its ownK233607 MagnetOs Easypack PuttyKuros Biosciences B.V · 2023
- Descendant · 5 generations on · 1 of its ownK241212 MagnetOs Easypack PuttyKuros Biosciences · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K132071Bioactive Bone Graft PuttyBiostructures, LLC · 2014 · cites it directly6descendants
- K171563MagnetOs PuttyKuros Biosciences B.V · 2017 · 2 generations on4descendants
- K211201MagnetOs Easypack PuttyKuros Biosciences B.V · 2021 · 3 generations on3descendants
- K233607MagnetOs Easypack PuttyKuros Biosciences B.V · 2023 · 4 generations on2descendants
- K241212MagnetOs Easypack PuttyKuros Biosciences · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −3 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −2 | K021336 | Novabone-Resorbable Bone Graft Substitute | Novabone Products, LLC | 2002 | — |
| −1 | K092541 | Interface | Biostructures | 2010 | — |
| 0 (this device) | K112857 | Interface Bone Void Filler | Biostructures, LLC | 2011 | — |
| +1 | K132071 | Bioactive Bone Graft Putty | Biostructures, LLC | 2014 | 1 |
| +2 | K171563 | MagnetOs Putty | Kuros Biosciences B.V | 2017 | — |
| +3 | K211201 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2021 | — |
| +4 | K233607 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2023 | — |
| +5 | K241212 | MagnetOs Easypack Putty | Kuros Biosciences | 2024 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K092541 | InterfaceSummary page 2…ch of which has been determined by FDA to be substantially equivalent to pre- amendment devices: BioStructures LLC, Interface Bone Void Filler, cleared under K092541; and NovaBone Products, LLC, NovaBone Resorbable Bone Graft Substitute, cleared under K02 1336. The subject dev… | 2010 |
| * | K021336 | Novabone-Resorbable Bone Graft SubstituteSummary page 2…BioStructures LLC, Interface Bone Void Filler, cleared under K092541; and NovaBone Products, LLC, NovaBone Resorbable Bone Graft Substitute, cleared under K02 1336. The subject device and the predicate devices have the same intended use and have the same technological characteristics.… | 2002 |
What descends from it? (8)
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?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K132071 (Biostructures, LLC, 2014) has gone furthest, with 6 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. 2011, 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 nlot intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Jnterface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis), or in the posterolateral spine when mixed with autograft. 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/K112857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112857: Interface Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112857
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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