# K093447: Carrigen

- Pathway: 510(k) (Special)
- Applicant: Etex Corp.
- Decided: Feb 18, 2010 after 105 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: 8 generations back to K960978 (1996). 37 ancestors in all.
21 later devices descend from it; 4 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062630: Ossipro Bone Substitute Material, Etex Corp. (2007) Summary page 1.
- K090855: Equivabone Osteoinductive Bone Graft Substitute, Etex Corp. (2009) Summary page 1.
- K091607: Alpha-BSM, Beta-BSM, Gamma-BSM, Equivabone, Etex Corp. (2009) Summary page 1.

## Most influential descendants
- K101557: Gamma-BSM, Beta-BSM, Equivabone, Carigen (2010), 10 descendants of its own
- K103799: Inqu Paste Mix Plus (2011), 9 descendants of its own
- K130392: Kinex Bioactive (2013), 8 descendants of its own
- K102528: N-Force Fixation System (2011), 5 descendants of its own
- K173008: SCS 17-01 (2017), 4 descendants of its own

## Indications for use
CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral 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. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Source page: https://510kreport.com/device/K093447
Methodology: https://510kreport.com/methodology