510(k) · Cleared
ClearedIntergro DBM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine · MQV Filler, Bone Void, Calcium Compound
Cleared on Apr 2, 2009 after a 191-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Apr 2, 2009
- Review
- 191 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK082793 Intergro DBMBiomet Spine · 2009
- Descendant · cites it directly · 1 of its ownK140844 Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CCSynergy Biomedical, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK243609 EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK173301 BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC · 2018
Most influential descendants
Showing 3 of 3 · See all- K140844Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CCSynergy Biomedical, Inc. · 2014 · cites it directly1descendant
- K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation · 2024 · cites it directly0descendants
- K173301BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082793 | Intergro DBM | Biomet Spine | 2009 | — |
| +1 | K140844 | Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CC | Synergy Biomedical, Inc. | 2014 | — |
| +1 | K243609 | EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) | Etex Corporation | 2024 | — |
| +2 | K173301 | BioSphere MIS Putty (BioSphere MIS) | Synergy Biomedical, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | — | DynaGraft II Named without a submission number | |
| * | — | DBX Named without a submission number | |
| * | — | InterGro DBM Named without a submission number |
What descends from it? (3)
2 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?
- Of its descendants, K140844 (Synergy Biomedical, Inc., 2014) has gone furthest, with 1 descendant 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. 2009, 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?
InterGro DBM products (Putty, Paste, Plus) are to be used for filling bony voids or gaps in the extremities and pelvis that are not intrinsic to the bony stability of the structure, and as an autograft extender in the spine. InterGro Plus may also be used as a bone void filler in the spine (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. InterGro DBM may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm2. The amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082793 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082793: Intergro DBM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082793
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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