510(k) · Cleared
ClearedBgran Synthetic Osteoconductive Scaffoid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthos (Uk) Limited · MQV Filler, Bone Void, Calcium Compound
Cleared on Aug 25, 2004 as substantially equivalent to K032409 (Orthovita, Inc., 2003) and 1 other predicate after a 71-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it.
- Decided
- Aug 25, 2004
- Review
- 71 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K013072 (2002). 3 ancestors in all, the oldest K014156 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK013072 Chronos Tricalcium Prosphate (Chronos TCP)Synthes · 2002
- 1 generation backK032409 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita, Inc. · 2003
- This deviceK041616 Bgran Synthetic Osteoconductive ScaffoidOrthos (Uk) Limited · 2004
- Descendant · cites it directly · 0 of its ownK143692 GranOSTM - beta tricalcium phosphate synthetic bone granulesTcm Associates, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK061311 Allogran-RBiocomposites, Ltd. · 2006
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 |
|---|---|---|---|---|---|
| −2 | K013072 | Chronos Tricalcium Prosphate (Chronos TCP) | Synthes | 2002 | — |
| −1 | K032409 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita, Inc. | 2003 | — |
| 0 (this device) | K041616 | Bgran Synthetic Osteoconductive Scaffoid | Orthos (Uk) Limited | 2004 | — |
| +1 | K143692 | GranOSTM - beta tricalcium phosphate synthetic bone granules | Tcm Associates, Ltd. | 2015 | — |
| +1 | K061311 | Allogran-R | Biocomposites, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K032409 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 1…THO osteoconductive scaffold Cancellous Bone Void Filler 510(k) Registration No: K032409 K0141S6 Common Name Resorbable Synthetic Bone Void Filler/Bone Graft Substitute… | 2003 |
| * | K014156 | Cerasorb OrthoSummary page 2…osteoconductive scaffold Cancellous Bone Void Filler 510(k) Registration No: K032409 K014156 The devices intended use is As a bone void filler for As a bone void filler for… | 2002 |
What descends from it? (2)
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?
- The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K143692 (Tcm Associates, Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K032409.
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?
OIGran Synthetic Osteoconductive Scaffold Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. flGran Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. BGran Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.…
Read the full statement (129 words)
OIGran Synthetic Osteoconductive Scaffold Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. flGran Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. BGran Scaffold should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
BGran Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041616: Bgran Synthetic Osteoconductive Scaffoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041616
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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