510(k) · Cleared
ClearedCarricell
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etex Corporation · MQV Filler, Bone Void, Calcium Compound
Cleared on Feb 20, 2015 as substantially equivalent to K063050 (Etex Corp., 2007) and 2 other predicates after a 525-day review. Its family tree reaches back 5 generations to 1997. 3 later devices descend from it.
- Decided
- Feb 20, 2015
- Review
- 525 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K963562 (1997). 17 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
- 4 generations backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
- 3 generations backK040755 Exactech Resorbable Room Temperature Bone PasteExactech, Inc. · 2004
- 2 generations backK043048 Grafton Plus DBM PasteOsteotech, Inc. · 2005 · Recalled
- 1 generation backK060794 Progenix DBM Putty and PasteMedtronic Sofamor Danek · 2006
- This deviceK132868 CarricellEtex Corporation · 2015
- Descendant · cites it directly · 2 of its ownK163621 Vitoss Bioactive (BA) InjectableOrthovita, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK242797 OsteoFlo HydroFiberSurGenTec, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK243949 OsteoFlo HydroFiberSurGenTec, LLC · 2025
Most influential descendants
Showing 3 of 3 · See allView 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 | K040755 | Exactech Resorbable Room Temperature Bone Paste | Exactech, Inc. | 2004 | — |
| −2 | K043048 | Grafton Plus DBM Paste | Osteotech, Inc. | 2005 | 15 |
| −1 | K060794 | Progenix DBM Putty and Paste | Medtronic Sofamor Danek | 2006 | — |
| 0 (this device) | K132868 | Carricell | Etex Corporation | 2015 | — |
| +1 | K163621 | Vitoss Bioactive (BA) Injectable | Orthovita, Inc. | 2017 | — |
| +2 | K242797 | OsteoFlo HydroFiber | SurGenTec, LLC | 2024 | — |
| +2 | K243949 | OsteoFlo HydroFiber | SurGenTec, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2024 | 1 | 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? (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 4…ium Compound (21 CFR §888.3045) Proprietary Name: CarriCell® Bone Substitute Material Predicate Device(s): EquivaBone® Osteoinductive Bone Graft Substitute cleared per K063050 (ETEX Corporation) CarriGen® Porous Bone Substitute Material cleared per K062630 (ETEX… | 2007 |
| * | K062630 | Ossipro Bone Substitute MaterialSummary page 4…teoinductive Bone Graft Substitute cleared per K063050 (ETEX Corporation) CarriGen® Porous Bone Substitute Material cleared per K062630 (ETEX Corporation) PROGENIX® DBM Putty per K060794 (Medtronic Sofamor Danek) Device De… | 2007 |
| * | K060794 | Progenix DBM Putty and PasteSummary page 4…) CarriGen® Porous Bone Substitute Material cleared per K062630 (ETEX Corporation) PROGENIX® DBM Putty per K060794 (Medtronic Sofamor Danek) Device Description: CarriCell® Bone Substitute Material is a synthetic, biocompatible bone… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163621 | Vitoss Bioactive (BA) Injectable | 2017 | 2 |
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 18 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 17 ancestors have a recall of any class.
- Of its descendants, K163621 (Orthovita, Inc., 2017) has gone furthest, with 2 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. 2015, 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?
CarriCell® is indicated for filling bone voids or defects of the skeletal system (i.e., extremities 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. CarriCell® may be hydrated with saline or autologous blood prior to implantation. CarriCell® 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/K132868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132868: Carricell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132868
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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