510(k) · Cleared
ClearedMarrow Plus (M+)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Berkeley Advanced Biomaterials, Inc. · MQV Filler, Bone Void, Calcium Compound
Cleared on Jul 19, 2005 after a 26-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jul 19, 2005
- Review
- 26 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK051695 Marrow Plus (M+)Berkeley Advanced Biomaterials, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK063346 Pro Osteon 500REbi, L.P. · 2007
Most influential descendants
Showing 1 of 1 · See all- K063346Pro Osteon 500REbi, L.P. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051695 | Marrow Plus (M+) | Berkeley Advanced Biomaterials, Inc. | 2005 | — |
| +1 | K063346 | Pro Osteon 500R | Ebi, L.P. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063346 | Pro Osteon 500R | 2007 | 0 |
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?
- Of its descendants, K063346 (Ebi, L.P., 2007) has gone furthest, with 0 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.
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?
Marrow Plus (M+TM) is intended for use as a system for the aspiration of bone marrow, either autologous blood, plasma or other blood components. Prior to use, the syringe is pre-filled or filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This system provides the surgeon with a convenient way to mix blood or marrow with bone void filler (bone graft) and deliver the material to the orthopaedic…
Read the full statement (198 words)
Marrow Plus (M+TM) is intended for use as a system for the aspiration of bone marrow, either autologous blood, plasma or other blood components. Prior to use, the syringe is pre-filled or filled with the surgeon's choice of bone void filler (allograft, autograft or synthetic bone graft material). This system provides the surgeon with a convenient way to mix blood or marrow with bone void filler (bone graft) and deliver the material to the orthopaedic surgical site.
M+ may be pre-filled with synthetic bone substitute (Bi-Ostetic, Cem-Ostetic, Tri-Ostetic, BioPlus, GenerOs) shaped as granules or blocks (cancellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules or blocks may be pressed into the void or into the surgical site by hand. The granules or blocks provide void filling material that acts as a temporary support medium. The granules or blocks are not intended to provide structural support during the healing process. The implant is radio-opaque. It is biocompatible and resorbs in the body as bone ingrowth occurs.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051695 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051695: Marrow Plus (M+).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051695
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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