510(k) · Cleared
ClearedEquivabone
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 Mar 24, 2009 as substantially equivalent to K063050 (Etex Corp., 2007) and 1 other predicate after a 46-day review. Its family tree reaches back 5 generations to 1997. 28 later devices descend from it.
- Decided
- Mar 24, 2009
- Review
- 46 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K963562 (1997). 13 ancestors in all. 28 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
- 4 generations backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
- 3 generations backK053098 Optium DBM Gel and PuttyLifenet · 2005
- 2 generations backK063050 Cap PlusEtex Corp. · 2007
- 1 generation backK080329 Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008
- This deviceK090310 EquivaboneEtex Corp. · 2009
- Descendant · cites it directly · 25 of its ownK090855 Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009
- Descendant · 2 generations on · 21 of its ownK093447 CarrigenEtex Corp. · 2010
- Descendant · 2 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 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp. · 2009 · cites it directly25descendants
- K093447CarrigenEtex Corp. · 2010 · 2 generations on21descendants
- K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp. · 2010 · 2 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 |
|---|---|---|---|---|---|
| −5 | K963562 | Wright Plaster of Paris Pellets | Wrightmedicaltechnologyinc | 1997 | — |
| −4 | K020078 | Exactech Resorbable Bone Paste | Exactech, Inc. | 2004 | — |
| −3 | K053098 | Optium DBM Gel and Putty | Lifenet | 2005 | — |
| −2 | K063050 | Cap Plus | Etex Corp. | 2007 | — |
| −1 | K080329 | Cap Plus, Equivabone, Cap/DBM | Etex Corp. | 2008 | — |
| 0 (this device) | K090310 | Equivabone | Etex Corp. | 2009 | — |
| +1 | K090855 | Equivabone Osteoinductive Bone Graft Substitute | Etex Corp. | 2009 | — |
| +2 | K093447 | Carrigen | Etex Corp. | 2010 | — |
| +2 | 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 |
|---|---|---|
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 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? (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 |
|---|---|---|---|
| * | K063050 | Cap PlusSummary page 1…ne Void, Osteoinductive (21 CFR 888.3045) Proprietary Name: EquivaBone Osteoinductive Bone Graft Substitute Predicate Device(s): CaP Plus (K063050) CaP Plus (K080329) Device Description: EquivaBone is a biocompatible bone graft… | 2007 |
| * | K080329 | Cap Plus, Equivabone, Cap/DBMSummary page 1…Proprietary Name: EquivaBone Osteoinductive Bone Graft Substitute Predicate Device(s): CaP Plus (K063050) CaP Plus (K080329) Device Description: EquivaBone is a biocompatible bone graft substitute material… | 2008 |
What descends from it? (28)
See all 282 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 12 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K090855 (Etex Corp., 2009) has gone furthest, with 25 descendants of its own.
- 3 other devices also cite its predicate K063050.
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?
EquivaBone is intended for use in filling bone voids or defects of the skeletal system (such as the. extremities, spine, and the 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. It 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/K090310 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090310: Equivabone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090310
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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