510(k) · Cleared
ClearedModification to MBCP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomatlante · MQV Filler, Bone Void, Calcium Compound
Cleared on May 3, 2005 as substantially equivalent to K032268 (Biomatlante, 2003) after a 183-day review. Its family tree reaches back 3 generations to 1999. 122 later devices descend from it.
- Decided
- May 3, 2005
- Review
- 183 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K990131 (1999). 4 ancestors in all. 122 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 2 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 1 generation backK032268 MBCPBiomatlante · 2003
- This deviceK043005 Modification to MBCPBiomatlante · 2005
- Descendant · cites it directly · 60 of its ownK051774 MBCPBiomatlante · 2006
- Descendant · cites it directly · 59 of its ownK051885 MBCPBiomatlante · 2005
- Descendant · 2 generations on · 47 of its ownK071813 Mastergraft PuttyMedtronic Sofamor Danek · 2007
- Descendant · 2 generations on · 40 of its ownK060732 MBCP GelBiomatlante · 2006
- Descendant · 3 generations on · 38 of its ownK082166 Mastergraft StripMedtronic Sofamor Danek · 2009
Showing 5 of 122 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 122 · See all- K051774MBCPBiomatlante · 2006 · cites it directly60descendants
- K051885MBCPBiomatlante · 2005 · cites it directly59descendants
- K071813Mastergraft PuttyMedtronic Sofamor Danek · 2007 · 2 generations on47descendants
- K060732MBCP GelBiomatlante · 2006 · 2 generations on40descendants
- K082166Mastergraft StripMedtronic Sofamor Danek · 2009 · 3 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −2 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −1 | K032268 | MBCP | Biomatlante | 2003 | — |
| 0 (this device) | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| +1 | K051774 | MBCP | Biomatlante | 2006 | — |
| +1 | K051885 | MBCP | Biomatlante | 2005 | — |
| +2 | K071813 | Mastergraft Putty | Medtronic Sofamor Danek | 2007 | — |
| +2 | K060732 | MBCP Gel | Biomatlante | 2006 | — |
| +3 | K082166 | Mastergraft Strip | Medtronic Sofamor Danek | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 9 | 0 |
| 2010 | 6 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 0 |
| 2022 | 9 | 0 |
| 2023 | 10 | 0 |
| 2024 | 12 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K032268 | MBCPSummary page 2…ion. 5. SUBSTANTIAL EQUIVALENCE INFORMATION The intended use and material composition of MBCPTM Bone Graft Substitute is the same as previously cleared MBCP TM (K032268). MBCP T M Bone Graft Substitute and the predicate devices are substantially equivalent in design, materials of construction… | 2003 |
What descends from it? (122)
See all 1226 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 6 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K051774 (Biomatlante, 2006) has gone furthest, with 60 descendants of its own.
- 10 other devices also cite its predicate K032268.
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?
MBCPTM is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. MBCPTM can be used with autograft as a bone graft extender. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP TM is a bone filler without initial mechanical properties. Therefore rigid…
Read the full statement (141 words)
MBCPTM is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. MBCPTM can be used with autograft as a bone graft extender. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
MBCP TM is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
When packed into a bony site, MBCP TM gradually resorbs and is replaced with bone during the healing process.
In addition, when used with appropriate opening osteotomy system devices, plates and screws, MBCPTM is intended to be used as a bone void filler in femoral or tibial osteotomies.
MBCPTM is to be used in association with adequate post-operative immobilization.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043005: Modification to MBCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043005
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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