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 May 7, 2004 as substantially equivalent to K021551 (Biocomposites, Ltd., 2002) and 3 other predicates after a 60-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- May 7, 2004
- Review
- 60 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K994337 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
- This deviceK040600 Genex Bone Graft SubstituteBiocomposites, Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita Co. | 2000 | — |
| 0 (this device) | K040600 | Genex Bone Graft Substitute | Biocomposites, Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K021551 | Stimulan - Calcium Sulfate Bone Void Filler KitSummary page 1…Calcium Sulphate Preformed Pellets (3) Legally marketed predicate device: Stimulan® Bone Void Filler Kit Biocomposites Ltd K021551 Vitoss T M Scaffold Orthovita Inc K994337 Therifil TM Bone Void… | 2002 |
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 1…ne Void Filler Kit Biocomposites Ltd K021551 Vitoss T M Scaffold Orthovita Inc K994337 Therifil TM Bone Void Filler Therics Inc K031040 Cem-Ostetic Bone Void… | 2000 |
| * | K031040 | Therifil Bone FillerSummary page 1…caffold Orthovita Inc K994337 Therifil TM Bone Void Filler Therics Inc K031040 Cem-Ostetic Bone Void Filler Berkeley Advanced Biomaterials Inc K022622 (4) Subject device descrip… | 2003 |
| * | K022622 | Cem-Ostetic, Models Cemo-020O, Cemo-05P, Cemo-10P, Cemo-20P, and Cemo-30PSummary page 1…Bone Void Filler Therics Inc K031040 Cem-Ostetic Bone Void Filler Berkeley Advanced Biomaterials Inc K022622 (4) Subject device description: Genex® Bone Graft Substitute consists of synthetic bioabsorbable calcium salts, pre-… | 2003 |
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?
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K021551.
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?
Genex ® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure.
Genex7 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 ® provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
Genex ® is provided sterile for singe use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040600: 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/K040600
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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