# K170165: Osteo-P Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Molecular Matrix, Inc.
- Decided: Dec 29, 2017 after 344 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 K960978 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063359: INQU, Isto Technologies, Inc. (2007) Summary page 4.

## Indications for use
Osteo-P™ Bone Graft Substitute is indicated for use only in the treatment of bony voids or gaps that are not intrinsic to the stability of the bony structure. It is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis), and the opening to the defect site sealed with bone wax. These defects may be surgically created osseous defects or osseous defects created from traumatic or degenerative injury to the bone. Subsequent to implantation, Osteo-P™ Bone Graft Substitute is resorbed and replaced with bone during the healing process.

Source page: https://510kreport.com/device/K170165
Methodology: https://510kreport.com/methodology