510(k) · Cleared
ClearedCap Plus
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 Nov 19, 2007 as substantially equivalent to K033138 (Etex Corp., 2003) and 3 other predicates after a 411-day review. Its family tree reaches back 3 generations to 1997. 34 later devices descend from it.
- Decided
- Nov 19, 2007
- Review
- 411 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K963562 (1997). 11 ancestors in all. 34 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
- 2 generations backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
- 1 generation backK053098 Optium DBM Gel and PuttyLifenet · 2005
- This deviceK063050 Cap PlusEtex Corp. · 2007
- Descendant · cites it directly · 29 of its ownK080329 Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008
- Descendant · cites it directly · 28 of its ownK090310 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
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K080329Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008 · cites it directly29descendants
- K090310EquivaboneEtex Corp. · 2009 · cites it directly28descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963562 | Wright Plaster of Paris Pellets | Wrightmedicaltechnologyinc | 1997 | — |
| −2 | K020078 | Exactech Resorbable Bone Paste | Exactech, Inc. | 2004 | — |
| −1 | K053098 | Optium DBM Gel and Putty | Lifenet | 2005 | — |
| 0 (this device) | K063050 | Cap Plus | Etex Corp. | 2007 | — |
| +1 | K080329 | Cap Plus, Equivabone, Cap/DBM | Etex Corp. | 2008 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K033138 | CAP3 Bone Substitute MaterialSummary page 1…Resorbable Calcium Salt Bone Void Filler Device PRODUCT CODE: MQV PREDICATE DEVICE(S): CaP 3 Bone Substitute Material (K033138) Optium DBMTM Gel & Putty (K053098) ALLOMATRIX ® Putty (K020895)… | 2003 |
| * | K053098 | Optium DBM Gel and PuttySummary page 1…id Filler Device PRODUCT CODE: MQV PREDICATE DEVICE(S): CaP 3 Bone Substitute Material (K033138) Optium DBMTM Gel & Putty (K053098) ALLOMATRIX ® Putty (K020895) InterGro® DBM (K031399) ETEX Corporation 510(k) CaP… | 2005 |
| * | K020895 | Allomatrix Model# 86Summary page 1…MQV PREDICATE DEVICE(S): CaP 3 Bone Substitute Material (K033138) Optium DBMTM Gel & Putty (K053098) ALLOMATRIX ® Putty (K020895) InterGro® DBM (K031399) ETEX Corporation 510(k) CaP Plus Submission K063050… | 2004 |
| * | K031399 | Intergro DBMSummary page 1…stitute Material (K033138) Optium DBMTM Gel & Putty (K053098) ALLOMATRIX ® Putty (K020895) InterGro® DBM (K031399) ETEX Corporation 510(k) CaP Plus Submission K063050 17Sep07… | 2005 |
What descends from it? (34)
See all 344 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 10 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K080329 (Etex Corp., 2008) has gone furthest, with 29 descendants of its own.
- 5 other devices also cite its predicate K033138.
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. 2007, 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?
CaP Plus is intended for use in filling bone voids or defects of the skeletal system (such as the extremities 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/K063050 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063050: Cap Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063050
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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