510(k) · Cleared
Recalled · Class II · 2019Bioactive Bone Graft Putty
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 Jan 10, 2014 as substantially equivalent to K071206 (Apatech, Ltd., 2007) and 3 other predicates after a 191-day review. Its family tree reaches back 5 generations to 1996. 6 later devices descend from it. It has been recalled once.
- Decided
- Jan 10, 2014
- Review
- 191 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 5 generations to K960978 (1996). 18 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 4 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 3 generations backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- 2 generations backK040082 Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004
- 1 generation backK071206 Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · Recalled
- This deviceK132071 Bioactive Bone Graft PuttyBiostructures, LLC · 2014
- Descendant · cites it directly · 4 of its ownK171563 MagnetOs PuttyKuros Biosciences B.V · 2017
- Descendant · 2 generations on · 3 of its ownK211201 MagnetOs Easypack PuttyKuros Biosciences B.V · 2021
- Descendant · 3 generations on · 2 of its ownK233607 MagnetOs Easypack PuttyKuros Biosciences B.V · 2023
- Descendant · 4 generations on · 1 of its ownK241212 MagnetOs Easypack PuttyKuros Biosciences · 2024
- Descendant · 5 generations on · 0 of its ownK243474 MagnetOs MISKuros Biosciences B.V · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171563MagnetOs PuttyKuros Biosciences B.V · 2017 · cites it directly4descendants
- K211201MagnetOs Easypack PuttyKuros Biosciences B.V · 2021 · 2 generations on3descendants
- K233607MagnetOs Easypack PuttyKuros Biosciences B.V · 2023 · 3 generations on2descendants
- K241212MagnetOs Easypack PuttyKuros Biosciences · 2024 · 4 generations on1descendant
- K243474MagnetOs MISKuros Biosciences B.V · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −4 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −3 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| −2 | K040082 | Pore-SI Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| −1 | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft Substitute | Apatech, Ltd. | 2007 | 1 |
| 0 (this device) | K132071 | Bioactive Bone Graft Putty | Biostructures, LLC | 2014 | — |
| +1 | K171563 | MagnetOs Putty | Kuros Biosciences B.V | 2017 | — |
| +2 | K211201 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2021 | — |
| +3 | K233607 | MagnetOs Easypack Putty | Kuros Biosciences B.V | 2023 | — |
| +4 | K241212 | MagnetOs Easypack Putty | Kuros Biosciences | 2024 | — |
| +5 | K243474 | MagnetOs MIS | Kuros Biosciences B.V | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (4)
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 |
|---|---|---|---|
| * | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteSummary page 1…n: Class 11 Classification Name: Filler, Bone Void, Calcium Compound Classification Number: 21 CFR 888.3045 Product Code: MQV Predicate Device(s): K071206, Actfuse®ABX, ApaTech Limited K043005, MBCP TM, Biomnatlante K1 12857, Interfac… | 2007 |
| * | K043005 | Modification to MBCPSummary page 1…um Compound Classification Number: 21 CFR 888.3045 Product Code: MQV Predicate Device(s): K071206, Actfuse®ABX, ApaTech Limited K043005, MBCP TM, Biomnatlante K1 12857, Interface Bone Void Filler, BioStructures, LLC… | 2005 |
| * | K112857 | Interface Bone Void FillerSummary page 1…duct Code: MQV Predicate Device(s): K071206, Actfuse®ABX, ApaTech Limited K043005, MBCP TM, Biomnatlante K1 12857, Interface Bone Void Filler, BioStructures, LLC K020078, Exactech Resorbable Bone Paste, Exactech, Inc.… | 2011 |
| * | K020078 | Exactech Resorbable Bone PasteSummary page 1…imited K043005, MBCP TM, Biomnatlante K1 12857, Interface Bone Void Filler, BioStructures, LLC K020078, Exactech Resorbable Bone Paste, Exactech, Inc. Indications for Use Bicactive Bone Graft Putty is a bone void filler device… | 2004 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 13, 2019 | Class II | Z-1148-2019 | Package design/selection | The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K171563 (Kuros Biosciences B.V, 2017) has gone furthest, with 4 descendants of its own.
- 11 other devices also cite its predicate K071206.
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. 2014, 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?
Bioactive Bone Graft Putty is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Bioactive Bone Graft Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine fusion procedures). Bioactive Bone Graft Putty can also be used with autograft as a bone graft extender in the posterolateral spine. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132071 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132071: Bioactive Bone Graft Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132071
Report an extraction error
Are you the manufacturer?
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