510(k) · Cleared
ClearedCAP3 Bone Substitute Material
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 Dec 2, 2003 as substantially equivalent to K011048 (DePuy Orthopaedics, Inc., 2001) after a 63-day review. Its family tree reaches back 1 generation to 2001. 39 later devices descend from it.
- Decided
- Dec 2, 2003
- Review
- 63 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011048 (2001). 39 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK011048 BSM Bone Substitute MaterialDePuy Orthopaedics, Inc. · 2001
- This deviceK033138 CAP3 Bone Substitute MaterialEtex Corp. · 2003
- Descendant · cites it directly · 34 of its ownK063050 Cap PlusEtex Corp. · 2007
- Descendant · cites it directly · 29 of its ownK080329 Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008
- Descendant · 2 generations on · 28 of its ownK090310 EquivaboneEtex Corp. · 2009
- Descendant · cites it directly · 26 of its ownK072355 Ossifuse Bone Substitute MaterialEtex Corp. · 2007
- Descendant · cites it directly · 26 of its ownK062630 Ossipro Bone Substitute MaterialEtex Corp. · 2007
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K063050Cap PlusEtex Corp. · 2007 · cites it directly34descendants
- K080329Cap Plus, Equivabone, Cap/DBMEtex Corp. · 2008 · cites it directly29descendants
- K090310EquivaboneEtex Corp. · 2009 · 2 generations on28descendants
- K072355Ossifuse Bone Substitute MaterialEtex Corp. · 2007 · cites it directly26descendants
- K062630Ossipro Bone Substitute MaterialEtex Corp. · 2007 · cites it directly26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011048 | BSM Bone Substitute Material | DePuy Orthopaedics, Inc. | 2001 | — |
| 0 (this device) | K033138 | CAP3 Bone Substitute Material | Etex Corp. | 2003 | — |
| +1 | K063050 | Cap Plus | Etex Corp. | 2007 | — |
| +1 | K080329 | Cap Plus, Equivabone, Cap/DBM | Etex Corp. | 2008 | — |
| +2 | K090310 | Equivabone | Etex Corp. | 2009 | — |
| +1 | K072355 | Ossifuse Bone Substitute Material | Etex Corp. | 2007 | — |
| +1 | K062630 | Ossipro Bone Substitute Material | Etex Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 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? (1)
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 |
|---|---|---|---|
| * | K011048 | BSM Bone Substitute MaterialSummary page 1…Resorbable Calcium Salt Bone Void Filler Device PRODUCT CODE: MQV PREDICATE DEVICES: a-BSM® Bone Substitute Material (K011048) ETEX Corporation 33 9/24/2003 DEVICE DESCRIPTION: CaP 3T… | 2001 |
What descends from it? (39)
See all 396 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?
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?
CaP 3 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. CaP 3 Bone Substitute Material is a bone graft substitute that resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033138 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033138: CAP3 Bone Substitute Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033138
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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