# K063527: MBCP+

- Pathway: 510(k) (Traditional)
- Applicant: Biomatlante
- Decided: Jul 30, 2007 after 250 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963587 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040514: Eovia Calcium Phosphate Ceramic, Ortho Tec, LLC (2004) Summary page 1.
- K033258: Bonesave Bone Void Filler, Howmedica Osteonics (2004) Summary page 1.

## Recalls of this device
- Jan 31, 2011 · Not classified · Z-1677-2011: The OsteoMatrix Synthetic Bone Graft Composite Instructions for Use document, P4G10A/Rev. 01 had language that was not consistent with the cleared indications.

## Indications for use
MBCP+ TM is intended for use as bone void filler for bony voids or gaps of the skeletal system (e.g. 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. MBCP+Tm is provided sterile for single patient use.

Source page: https://510kreport.com/device/K063527
Methodology: https://510kreport.com/methodology