510(k) · Cleared
ClearedOssatura BCP Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isotis NV · MQV Filler, Bone Void, Calcium Compound
Cleared on May 20, 2003 as substantially equivalent to K994337 (Orthovita Co., 2000) and 1 other predicate after a 126-day review. Its family tree reaches back 2 generations to 1996. 133 later devices descend from it.
- Decided
- May 20, 2003
- Review
- 126 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960978 (1996). 4 ancestors in all. 133 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 1 generation backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- This deviceK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- Descendant · cites it directly · 113 of its ownK040082 Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004
- Descendant · 2 generations on · 111 of its ownK071206 Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · Recalled
- Descendant · cites it directly · 79 of its ownK090641 CuriosProgentix Orthobiology BV · 2009
- Descendant · 3 generations on · 79 of its ownK080736 Actifuse Shape Bone Graft SubstituteApatech, Ltd. · 2008
- Descendant · 2 generations on · 76 of its ownK151584 AttraX PuttyProgentix Orthobiology BV · 2015
Showing 5 of 133 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 133 · See all- K040082Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004 · cites it directly113descendants
- K071206Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · 2 generations on111descendants
- K090641CuriosProgentix Orthobiology BV · 2009 · cites it directly79descendants
- K080736Actifuse Shape Bone Graft SubstituteApatech, Ltd. · 2008 · 3 generations on79descendants
- K151584AttraX PuttyProgentix Orthobiology BV · 2015 · 2 generations on76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −1 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| 0 (this device) | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| +1 | K040082 | Pore-SI Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| +2 | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft Substitute | Apatech, Ltd. | 2007 | 1 |
| +1 | K090641 | Curios | Progentix Orthobiology BV | 2009 | — |
| +3 | K080736 | Actifuse Shape Bone Graft Substitute | Apatech, Ltd. | 2008 | — |
| +2 | K151584 | AttraX Putty | Progentix Orthobiology BV | 2015 | — |
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 |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 25 | 0 |
| 2025 | 20 | 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? (2)
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 |
|---|---|---|---|
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 1…Classification Name: Bone void filler (Unclassified) 3. PREDICATE DEVICES VitossTMscaffold Synthetic Cancellous Bone void filler(K994337) Pro Osteon@500(R) Resorbable Bone void filler (K9808 17) 4. DEVICEDESCRIPTION OsSaturaTMBCP is a syn… | 2000 |
| * | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…Summary page 1…PREDICATE DEVICES VitossTMscaffold Synthetic Cancellous Bone void filler(K994337) Pro Osteon@500(R) Resorbable Bone void filler (K9808 17) 4. DEVICEDESCRIPTION OsSaturaTMBCP is a synthetic, osteoconductive bone void filler, which consists of a bi… | 1998 |
What descends from it? (133)
See all 1336 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 7 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K040082 (Apatech, Ltd., 2004) has gone furthest, with 113 descendants of its own.
- 25 other devices also cite its predicate K994337.
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?
OsSaturaTMBCP (Biphasic Calcium Phosphate) is bone void filler intended only for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OsSaturaTMBCP is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides 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/K030131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030131: Ossatura BCP Bone Void Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030131
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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