# K063157: Merries K-Phate Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Merries International, Inc.
- Decided: Mar 10, 2008 after 510 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: 5 generations back to K990131 (1999). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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.
- K051774: MBCP, Biomatlante (2006) Summary page 2.
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 2.
- K032409: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita, Inc. (2003) Summary page 2.
- K033258: Bonesave Bone Void Filler, Howmedica Osteonics (2004) Summary page 2.

## Indications for use
Merries K-PHATE is intended to be packed into bony defects of the skeletal system ( extremities, spine, or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.

Source page: https://510kreport.com/device/K063157
Methodology: https://510kreport.com/methodology