510(k) · Cleared
ClearedGenex Bone Graft Substitute
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocomposites, Ltd. · MQV Filler, Bone Void, Calcium Compound
Cleared on Feb 4, 2022 as substantially equivalent to K082381 (Biocomposites, Ltd., 2008) after a 161-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Feb 4, 2022
- Review
- 161 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082381 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK082381 GENEXBiocomposites, Ltd. · 2008
- This deviceK212721 Genex Bone Graft SubstituteBiocomposites, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082381 | GENEX | Biocomposites, Ltd. | 2008 | — |
| 0 (this device) | K212721 | Genex Bone Graft Substitute | Biocomposites, Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K082381 | GENEXSummary page 5…replaced with bone during the healing process Summary of Technology: Genex® Bone Graft Substitute is substantially equivalent to the primary predicate device Genex® (K082381). Technological differences are that the subject device Genex® Bone Graft Substitute is presented as a closed mixing system compa… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2022, 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?
Genex® Bone Graft Substitute injectable paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process. * Genex® Bone Graft Substitute is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure * Genex® Bone Graft Substitute is indicated to be gently packed into voids or defects of the skeletal system (ie long bones, extremities, posterolateral spine and pelvis)…
Read the full statement (143 words)
Genex® Bone Graft Substitute injectable paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
* Genex® Bone Graft Substitute is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure
* Genex® Bone Graft Substitute is indicated to be gently packed into voids or defects of the skeletal system (ie long bones, extremities, posterolateral spine and pelvis)
* Genex® Bone Graft Substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect
* The bony defects or cavities may be surgically created or the result of traumatic injury. Genex® Bone Graft Substitute provides a bone graft substitute that resorbs and is replaced with bone during the healing process
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212721: Genex 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/K212721
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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