# K080329: Cap Plus, Equivabone, Cap/DBM

- Pathway: 510(k) (Traditional)
- Applicant: Etex Corp.
- Decided: Apr 28, 2008 after 81 days
- Product code: MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor))
- 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: 4 generations back to K963562 (1997). 12 ancestors in all.
29 later devices descend from it; 3 cite it directly.
0 of 42 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 1.
- K033138: CAP3 Bone Substitute Material, Etex Corp. (2003) Summary page 1.
- K053098: Optium DBM Gel and Putty, Lifenet (2005) Summary page 1.

## Most influential descendants
- K090310: Equivabone (2009), 28 descendants of its own
- K090855: Equivabone Osteoinductive Bone Graft Substitute (2009), 25 descendants of its own
- K093447: Carrigen (2010), 21 descendants of its own
- K101557: Gamma-BSM, Beta-BSM, Equivabone, Carigen (2010), 10 descendants of its own
- K103799: Inqu Paste Mix Plus (2011), 9 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K080329
Methodology: https://510kreport.com/methodology