# K032268: MBCP

- Pathway: 510(k) (Traditional)
- Applicant: Biomatlante
- Decided: Dec 11, 2003 after 141 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: 2 generations back to K990131 (1999). 3 ancestors in all.
142 later devices descend from it; 11 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 1.
- K020986: Mastergraft Resorbable Ceramic, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 1.

## Most influential descendants
- K043005: Modification to MBCP (2005), 122 descendants of its own
- K051774: MBCP (2006), 60 descendants of its own
- K051885: MBCP (2005), 59 descendants of its own
- K071813: Mastergraft Putty (2007), 47 descendants of its own
- K060732: MBCP Gel (2006), 40 descendants of its own

## Indications for use
MBCP TM'is intended for use as a 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 a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, MBCP TM gradually resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K032268
Methodology: https://510kreport.com/methodology