510(k) · Cleared
ClearedCap Plus, Equivabone, Cap/DBM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etex Corp. · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Apr 28, 2008 as substantially equivalent to K063050 (Etex Corp., 2007) and 2 other predicates after an 81-day review. Its family tree reaches back 4 generations to 1997. 29 later devices descend from it.
- Decided
- Apr 28, 2008
- Review
- 81 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K963562 (1997). 12 ancestors in all. 29 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
- 3 generations backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
- 2 generations backK053098 Optium DBM Gel and PuttyLifenet · 2005
- 1 generation backK063050 Cap PlusEtex Corp. · 2007
- This deviceK080329 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
- Descendant · 3 generations on · 9 of its ownK103799 Inqu Paste Mix PlusIsto Technologies, Inc. · 2011
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- 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
- K103799Inqu Paste Mix PlusIsto Technologies, Inc. · 2011 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963562 | Wright Plaster of Paris Pellets | Wrightmedicaltechnologyinc | 1997 | — |
| −3 | K020078 | Exactech Resorbable Bone Paste | Exactech, Inc. | 2004 | — |
| −2 | K053098 | Optium DBM Gel and Putty | Lifenet | 2005 | — |
| −1 | K063050 | Cap Plus | Etex Corp. | 2007 | — |
| 0 (this device) | 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 | — |
| +3 | K103799 | Inqu Paste Mix Plus | Isto Technologies, Inc. | 2011 | — |
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 | 3 | 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 MBP? 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 MBP device
- #1 K242799 PliaFX Floscore 9.0 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K063050 | Cap PlusSummary page 1…Resorbable Calcium Salt Bone Void Filler Device PRODUCT CODE: MQV, MBP PREDICATE DEVICE(S): CaP Plus Bone Substitute Material (K063050) CaP 3 Bone Substitute Material (K033138) Optium DBMTM Gel & Putty (K053098)… | 2007 |
| * | K033138 | CAP3 Bone Substitute MaterialSummary page 1…e PRODUCT CODE: MQV, MBP PREDICATE DEVICE(S): CaP Plus Bone Substitute Material (K063050) CaP 3 Bone Substitute Material (K033138) Optium DBMTM Gel & Putty (K053098) - 34 - ETEX Corpora… | 2003 |
| * | K053098 | Optium DBM Gel and PuttySummary page 1…ICATE DEVICE(S): CaP Plus Bone Substitute Material (K063050) CaP 3 Bone Substitute Material (K033138) Optium DBMTM Gel & Putty (K053098) - 34 - ETEX Corporation 5 10(k) CaP Plus Submission… | 2005 |
What descends from it? (29)
See all 293 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 11 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K090310 (Etex Corp., 2009) has gone furthest, with 28 descendants of its own.
- 3 other devices also cite its predicate K063050.
How does its category compare?
All MBP devicesMBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MBP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MBP
181in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBP
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBP
2in 2025
MAUDE reports naming product code MBP, 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 | 5 | 188 | 0 | 7 |
| 2008 | 5 | 93 | 0 | 15 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 1 | — | 2 | 18 |
| 2012 | 1 | — | 13 | 24 |
| 2013 | 3 | 181 | 0 | 16 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 7 | 6 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 2 | — |
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, 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/K080329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080329: Cap Plus, Equivabone, Cap/DBM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080329
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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