510(k) · Cleared
ClearedGamma-BSM, Beta-BSM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etex Corp. · MQV Filler, Bone Void, Calcium Compound
Cleared on Feb 20, 2009 as substantially equivalent to K072355 (Etex Corp., 2007) and 2 other predicates after an 18-day review. Its family tree reaches back 3 generations to 2001. 25 later devices descend from it.
- Decided
- Feb 20, 2009
- Review
- 18 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K011048 (2001). 4 ancestors in all. 25 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK011048 BSM Bone Substitute MaterialDePuy Orthopaedics, Inc. · 2001
- 2 generations backK033138 CAP3 Bone Substitute MaterialEtex Corp. · 2003
- 1 generation backK072355 Ossifuse Bone Substitute MaterialEtex Corp. · 2007
- This deviceK090242 Gamma-BSM, Beta-BSMEtex Corp. · 2009
- Descendant · cites it directly · 22 of its ownK091607 Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp. · 2009
- Descendant · 2 generations on · 21 of its ownK093447 CarrigenEtex Corp. · 2010
- Descendant · 3 generations on · 10 of its ownK101557 Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp. · 2010
- Descendant · 3 generations on · 9 of its ownK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
- Descendant · 4 generations on · 8 of its ownK130392 Kinex BioactiveGlobus Medical, Inc. · 2013
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp. · 2009 · cites it directly22descendants
- K093447CarrigenEtex Corp. · 2010 · 2 generations on21descendants
- K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp. · 2010 · 3 generations on10descendants
- K103799Inqu Paste Mix PlusIsto Technologies, Inc. · 2011 · 3 generations on9descendants
- K130392Kinex BioactiveGlobus Medical, Inc. · 2013 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011048 | BSM Bone Substitute Material | DePuy Orthopaedics, Inc. | 2001 | — |
| −2 | K033138 | CAP3 Bone Substitute Material | Etex Corp. | 2003 | — |
| −1 | K072355 | Ossifuse Bone Substitute Material | Etex Corp. | 2007 | — |
| 0 (this device) | K090242 | Gamma-BSM, Beta-BSM | Etex Corp. | 2009 | — |
| +1 | K091607 | Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone | Etex Corp. | 2009 | — |
| +2 | K093447 | Carrigen | Etex Corp. | 2010 | — |
| +3 | K101557 | Gamma-BSM, Beta-BSM, Equivabone, Carigen | Etex Corp. | 2010 | — |
| +3 | K103799 | Inqu Paste Mix Plus | Isto Technologies, Inc. | 2011 | — |
| +4 | K130392 | Kinex Bioactive | Globus Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K072355 | Ossifuse Bone Substitute MaterialSummary page 1…e Material Predicate Device(s): Beta-bsm Injectable Bone Substitute Material (cleared as OssiFuse Bone Substitute Material, K072355) a-BSM (K072636) Device Description: Beta-bsm Injectable Bone Substitute Material i… | 2007 |
| * | K072636 | A-BSM Bone Substitute MaterialSummary page 1…-bsm Injectable Bone Substitute Material (cleared as OssiFuse Bone Substitute Material, K072355) a-BSM (K072636) Device Description: Beta-bsm Injectable Bone Substitute Material is a synthetic, bi… | 2007 |
| * | K033138 | CAP3 Bone Substitute MaterialSummary page 3…ne Substitute Material Predicate Device(s): Gamma-bsm Moldable Bone Substitute Material (cleared as CaP 3 Bone Void Filler, K033138) a-BSM (K072636) Device Description: Gamma-bsm Moldable Bone Substitute Material is… | 2003 |
What descends from it? (25)
See all 252 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 8 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K091607 (Etex Corp., 2009) has gone furthest, with 22 descendants of its own.
- 1 other device also cites its predicate K072355.
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?
Beta-bsm Injectable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.…
Read the full statement (182 words)
Beta-bsm Injectable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta-bsm Injectable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Gamma-bsm Moldable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system. (such as the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Gamma-bsm Moldable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090242 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090242: Gamma-BSM, Beta-BSM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090242
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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