510(k) · Cleared
ClearedGraftys BCP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graftys · MQV Filler, Bone Void, Calcium Compound
Cleared on Mar 11, 2008 as substantially equivalent to K051774 (Biomatlante, 2006) and 1 other predicate after a 133-day review. Its family tree reaches back 5 generations to 1999. 2 later devices descend from it.
- Decided
- Mar 11, 2008
- Review
- 133 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K990131 (1999). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 4 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
- 3 generations backK032268 MBCPBiomatlante · 2003
- 2 generations backK043005 Modification to MBCPBiomatlante · 2005
- 1 generation backK051774 MBCPBiomatlante · 2006
- This deviceK073064 Graftys BCPGraftys · 2008
- Descendant · cites it directly · 1 of its ownK082286 BioactysGraftys · 2009
- Descendant · 2 generations on · 0 of its ownK103820 Reprobone Dental Grafting MaterialCeramisys, Ltd. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −4 | K020986 | Mastergraft Resorbable Ceramic | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −3 | K032268 | MBCP | Biomatlante | 2003 | — |
| −2 | K043005 | Modification to MBCP | Biomatlante | 2005 | — |
| −1 | K051774 | MBCP | Biomatlante | 2006 | — |
| 0 (this device) | K073064 | Graftys BCP | Graftys | 2008 | — |
| +1 | K082286 | Bioactys | Graftys | 2009 | — |
| +2 | K103820 | Reprobone Dental Grafting Material | Ceramisys, Ltd. | 2011 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K051774 | MBCPSummary page 1…name: Code: MQV) 3. Legally Marketed Predicate Device Predicate MBCP TM - Resorbable calcium salt bone void filler device [K051774] VITOSS- Resorbable calcium salt bone void filler [K994337] 4. Device Description GR… | 2006 |
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 1…dicate MBCP TM - Resorbable calcium salt bone void filler device [K051774] VITOSS- Resorbable calcium salt bone void filler [K994337] 4. Device Description GRAFTYS®BCP is a sterile single use bioresorbable bone void filling substitute. GRAFT… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082286 | Bioactys | 2009 | 1 |
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?
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. 2008, 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?
GRAFTYS®BCP is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.
GRAFTYS BCP has limited initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
GRAFTYS®BCP can be used with autograft as a bone graft extender.
In addition when used with appropriate opening osteotomy system devices, plates and screws, GRAFTYS®BCP is intended to be used as a bone void filler in femoral or tibial osteotomies
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073064: Graftys BCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073064
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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