# K033138: CAP3 Bone Substitute Material

- Pathway: 510(k) (Traditional)
- Applicant: Etex Corp.
- Decided: Dec 2, 2003 after 63 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: 1 generation back to K011048 (2001). 1 ancestor in all.
39 later devices descend from it; 6 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011048: BSM Bone Substitute Material, DePuy Orthopaedics, Inc. (2001) Summary page 1.

## Most influential descendants
- K063050: Cap Plus (2007), 34 descendants of its own
- K080329: Cap Plus, Equivabone, Cap/DBM (2008), 29 descendants of its own
- K090310: Equivabone (2009), 28 descendants of its own
- K072355: Ossifuse Bone Substitute Material (2007), 26 descendants of its own
- K062630: Ossipro Bone Substitute Material (2007), 26 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K033138
Methodology: https://510kreport.com/methodology