510(k) · Cleared
Recalled · Class II · 2015Actifuse Bone Graft Substitute and E-Z-Fil and Shape Bone Graft Substitute
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 6, 2008 after a 118-day review. The FDA summary names no predicate by number. 9 later devices descend from it. It has been recalled once.
- Decided
- Nov 6, 2008
- Review
- 118 days
- Class
- Class II
- Product code
- MQV
- Recalls
- 1
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK081979 Actifuse Bone Graft Substitute and E-Z-Fil and Shape Bone Graft…Apatech, Ltd. · 2008
- Descendant · cites it directly · 7 of its ownK130531 UltrafuseBaxter Healthcare Corp · 2014
- Descendant · 2 generations on · 6 of its ownK181225 AltaporeBaxter Healthcare Corporation · 2018
- Descendant · 3 generations on · 4 of its ownK192363 AltaporeBaxter Healthcare Corporation · 2020
- Descendant · 3 generations on · 2 of its ownK191513 Altapore ShapeBaxter Healthcare Corporation · 2019
- Descendant · 4 generations on · 1 of its ownK201464 Altapore MISBaxter Healthcare Corporation · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K130531UltrafuseBaxter Healthcare Corp · 2014 · cites it directly7descendants
- K181225AltaporeBaxter Healthcare Corporation · 2018 · 2 generations on6descendants
- K192363AltaporeBaxter Healthcare Corporation · 2020 · 3 generations on4descendants
- K191513Altapore ShapeBaxter Healthcare Corporation · 2019 · 3 generations on2descendants
- K201464Altapore MISBaxter Healthcare Corporation · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081979 | Actifuse Bone Graft Substitute and E-Z-Fil and Shape Bone Graft Substitute | Apatech, Ltd. | 2008 | — |
| +1 | K130531 | Ultrafuse | Baxter Healthcare Corp | 2014 | — |
| +2 | K181225 | Altapore | Baxter Healthcare Corporation | 2018 | — |
| +3 | K192363 | Altapore | Baxter Healthcare Corporation | 2020 | — |
| +3 | K191513 | Altapore Shape | Baxter Healthcare Corporation | 2019 | — |
| +4 | K201464 | Altapore MIS | Baxter Healthcare Corporation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2024 | 2 | 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? (9)
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 |
|---|---|---|---|---|
| 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, K130531 (Baxter Healthcare Corp, 2014) has gone furthest, with 7 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 Flow Bone Graft Substitute 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 nA Flow Bone Graft Substitute can be injected Into bony voids or gaps of the skeletal system, Le.. extremities, pelvis, and spin~, including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be…
Read the full statement (396 words)
Actifuse TM Flow Bone Graft Substitute 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 nA Flow Bone Graft Substitute can be injected Into bony voids or gaps of the skeletal system, Le.. extremities, pelvis, and spin~, including use in posterolateral spinal 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.
Actifuse TM Shape 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
ActifuseTM 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
Actifuse T M 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/K081979 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081979: Actifuse Bone Graft Substitute and E-Z-Fil and Shape Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081979
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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