# K092608: Synthetic Mineral-Collagen Bone Graft Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: May 28, 2010 after 276 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: 6 generations back to K960978 (1996). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052812: Ossimend (TM) Bone Graft Material, Collagen Matrix, Inc. (2006) Summary page 1.

## Indications for use
Synthetic Mineral - Collagen Bone Graft Matrix, combined with autogenous bone marrow, is intended for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Synthetic Mineral - Collagen Bone Graft Matrix is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Source page: https://510kreport.com/device/K092608
Methodology: https://510kreport.com/methodology