# K240424: Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Mar 12, 2024 after 28 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: 26 generations back to K841189 (1984). 357 ancestors in all.
No later device cites it as a predicate yet.
1 of 358 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232315: Catalyst Bone Void Filler, Ossdsign AB (2023) Summary page 5.
- K231942: Mineral Collagen Composite Bioactive Extra Moldable, Collagen Matrix, Inc. (2023) Summary page 5.

## Indications for use
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. In the posterolateral spine and intervertebral disc space, Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender. When used in intervertebral body fusion procedures, Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Source page: https://510kreport.com/device/K240424
Methodology: https://510kreport.com/methodology