# K132868: Carricell

- Pathway: 510(k) (Traditional)
- Applicant: Etex Corporation
- Decided: Feb 20, 2015 after 525 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K963562 (1997). 17 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063050: Cap Plus, Etex Corp. (2007) Summary page 4.
- K062630: Ossipro Bone Substitute Material, Etex Corp. (2007) Summary page 4.
- K060794: Progenix DBM Putty and Paste, Medtronic Sofamor Danek (2006) Summary page 4.

## Most influential descendants
- K163621: Vitoss Bioactive (BA) Injectable (2017), 2 descendants of its own
- K242797: OsteoFlo HydroFiber (2024), 1 descendant of its own
- K243949: OsteoFlo HydroFiber (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K132868
Methodology: https://510kreport.com/methodology