510(k) · Cleared
ClearedApapore 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 May 7, 2004 as substantially equivalent to K030131 (Isotis NV, 2003) after a 163-day review. Its family tree reaches back 3 generations to 1996. 13 later devices descend from it.
- Decided
- May 7, 2004
- Review
- 163 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960978 (1996). 5 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 2 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 1 generation backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- This deviceK033722 Apapore Bone Graft SubstituteApatech, Ltd. · 2004
- Descendant · cites it directly · 10 of its ownK051951 Cerament Bone Void FillerBonesupport AB · 2005
- Descendant · 2 generations on · 6 of its ownK073316 Cerament Bone Void Filler, Model A0210Bonesupport AB · 2008
- Descendant · 3 generations on · 3 of its ownK201535 Cerament Bone Void FillerBonesupport AB · 2020
- Descendant · 4 generations on · 2 of its ownK212083 Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK071004 Osteocrete Bone Void FillerBone Solutions, Inc. · 2009
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K051951Cerament Bone Void FillerBonesupport AB · 2005 · cites it directly10descendants
- K073316Cerament Bone Void Filler, Model A0210Bonesupport AB · 2008 · 2 generations on6descendants
- K201535Cerament Bone Void FillerBonesupport AB · 2020 · 3 generations on3descendants
- K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc. · 2021 · 4 generations on2descendants
- K071004Osteocrete Bone Void FillerBone Solutions, Inc. · 2009 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −2 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −1 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| 0 (this device) | K033722 | Apapore Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| +1 | K051951 | Cerament Bone Void Filler | Bonesupport AB | 2005 | — |
| +2 | K073316 | Cerament Bone Void Filler, Model A0210 | Bonesupport AB | 2008 | — |
| +3 | K201535 | Cerament Bone Void Filler | Bonesupport AB | 2020 | — |
| +4 | K212083 | Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. | 2021 | — |
| +2 | K071004 | Osteocrete Bone Void Filler | Bone Solutions, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K030131 | Ossatura BCP Bone Void FillerSummary page 1…Isotis NV OsSatura TM BCP Bone Void Filler Isotis S.A. K030131 - cleared May 20, 2003 Intended use: ApaPore® is a bone void filler intended only for orthopedic applications as a filler for g… | 2003 |
What descends from it? (13)
See all 132 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 8 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K051951 (Bonesupport AB, 2005) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K030131.
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.
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?
ApaPore® is used in open bone voids that may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ApaPore® is intended for use on bone voids/gaps that are not intrinsic to the stability of the bony structure of the skeletal system, i.e., in the extremities, spine and pelvis.
ApaPore® is intended to be carefully packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine or pelvis). Following placement in the bony void, the synthetic bone void filler ApaPore® provides a scaffold for new mature host bone growth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033722: Apapore 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/K033722
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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