510(k) · Cleared
ClearedActifuse 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 Apr 16, 2008 as substantially equivalent to K071206 (Apatech, Ltd., 2007) after a 30-day review. Its family tree reaches back 5 generations to 1996. 79 later devices descend from it.
- Decided
- Apr 16, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K960978 (1996). 8 ancestors in all. 79 later devices descend from it, 4 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 deviceK080736 Actifuse Shape Bone Graft SubstituteApatech, Ltd. · 2008
- Descendant · cites it directly · 76 of its ownK151584 AttraX PuttyProgentix Orthobiology BV · 2015
- Descendant · cites it directly · 71 of its ownK191974 NuVasive AttraX PuttyNu Vasive, Incorporated · 2019
- Descendant · 2 generations on · 66 of its ownK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
- Descendant · 3 generations on · 29 of its ownK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
- Descendant · 3 generations on · 11 of its ownK223731 NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K151584AttraX PuttyProgentix Orthobiology BV · 2015 · cites it directly76descendants
- K191974NuVasive AttraX PuttyNu Vasive, Incorporated · 2019 · cites it directly71descendants
- K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated · 2021 · 2 generations on66descendants
- K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022 · 3 generations on29descendants
- K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023 · 3 generations on11descendants
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) | K080736 | Actifuse Shape Bone Graft Substitute | Apatech, Ltd. | 2008 | — |
| +1 | K151584 | AttraX Putty | Progentix Orthobiology BV | 2015 | — |
| +1 | K191974 | NuVasive AttraX Putty | Nu Vasive, Incorporated | 2019 | — |
| +2 | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar… | Nu Vasive, Incorporated | 2021 | — |
| +3 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | 2022 | — |
| +3 | K223731 | NuVasive Modulus-C Interbody System | Nuvasive, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 13 | 0 |
| 2024 | 24 | 0 |
| 2025 | 19 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteSummary page 1…ActifuseTM Shape Substitute Common Name: Bone Void Filler Predicate Device: Actifuse TM ABX E-Z-fil Putty, K071206 Intended use: ActifuseTM Shape is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids… | 2007 |
What descends from it? (79)
See all 794 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 12 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K151584 (Progentix Orthobiology BV, 2015) has gone furthest, with 76 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. 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 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080736 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080736: Actifuse Shape Bone Graft Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080736
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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