# K051774: MBCP

- Pathway: 510(k) (Traditional)
- Applicant: Biomatlante
- Decided: Jan 20, 2006 after 203 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: 4 generations back to K990131 (1999). 5 ancestors in all.
60 later devices descend from it; 10 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032268: MBCP, Biomatlante (2003) Summary page 2.
- K043005: Modification to MBCP, Biomatlante (2005) Summary page 2.

## Most influential descendants
- K071813: Mastergraft Putty (2007), 47 descendants of its own
- K082166: Mastergraft Strip (2009), 38 descendants of its own
- K140375: Mastergraft Putty, Mastergraft Strip (2014), 30 descendants of its own
- K181225: Altapore (2018), 6 descendants of its own
- K193075: Osteo3 ZP Putty (2020), 4 descendants of its own

## Indications for use
MBCPTM 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. MBCPTM can be used with autograft as a bone graft extender. 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. In addition, when used with appropriate opening osteotomy system devices, plates and screws, MBCPTM is intended to be used as a bone void filler in femoral or tibial osteotomies. MBCPTM is to be used in association with adequate post-operative immobilization.

Source page: https://510kreport.com/device/K051774
Methodology: https://510kreport.com/methodology