510(k) · Cleared
Recalled · Class II · 2015Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apatech, Ltd. · MQV Filler, Bone Void, Calcium Compound
Cleared on Nov 25, 2008 after an 81-day review. The FDA summary names no predicate by number. 56 later devices descend from it. It has been recalled once.
- Decided
- Nov 25, 2008
- Review
- 81 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 0
56 later devices descend from it, 11 citing it directly.
- This deviceK082575 Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft…Apatech, Ltd. · 2008
- Descendant · cites it directly · 25 of its ownK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- Descendant · 2 generations on · 21 of its ownK093447 CarrigenEtex Corp. · 2010
- Descendant · cites it directly · 10 of its ownK181958 MagnetOs PuttyKuros Biosciences B.V · 2018
- Descendant · 2 generations on · 10 of its ownK101557 Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp. · 2010
- Descendant · 3 generations on · 9 of its ownK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009 · cites it directly25descendants
- K093447CarrigenEtex Corp. · 2010 · 2 generations on21descendants
- K181958MagnetOs PuttyKuros Biosciences B.V · 2018 · cites it directly10descendants
- K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp. · 2010 · 2 generations on10descendants
- K103799Inqu Paste Mix PlusIsto Technologies, Inc. · 2011 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082575 | Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes | Apatech, Ltd. | 2008 | — |
| +1 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| +2 | K093447 | Carrigen | Etex Corp. | 2010 | — |
| +1 | K181958 | MagnetOs Putty | Kuros Biosciences B.V | 2018 | — |
| +2 | K101557 | Gamma-BSM, Beta-BSM, Equivabone, Carigen | Etex Corp. | 2010 | — |
| +3 | K103799 | Inqu Paste Mix Plus | Isto Technologies, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (56)
See all 5611 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090855 | Equivabone Osteoinductive Bone Graft Substitute | 2009 | 25 |
| K181958 | MagnetOs Putty | 2018 | 10 |
| K213111 | MagnetOs granules | 2022 | 7 |
| K130531 | Ultrafuse | 2014 | 7 |
| K091031 | Pioneer Surgical Nanoss BVF-E | 2009 | 7 |
| K211201 | MagnetOs Easypack Putty | 2021 | 3 |
| K141189 | Nanobone / Granulate | 2015 | 2 |
| K201464 | Altapore MIS | 2020 | 1 |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS | 2024 | 0 |
| K202639 | si-Mochi | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2015 | Class II | Z-1922-2016 | Process control | Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090855 (Etex Corp., 2009) has gone furthest, with 25 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. 2008, 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?
Actifuse TM is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware. 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 by bone during the healing process
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082575 · printed Nov 3, 2026
Cite this page
510(k) Report. “K082575: Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K082575
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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