# K182074: Mineral Collagen Composite Bioactive Moldable

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Mar 21, 2019 after 232 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: 9 generations back to K960978 (1996). 49 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute, Orthovita, Inc. (2008) Summary page 4.
- K140375: Mastergraft Putty, Mastergraft Strip, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.

## Most influential descendants
- K221735: Mineral Collagen Composite Bioactive Moldable (2022), 2 descendants of its own
- K231942: Mineral Collagen Composite Bioactive Extra Moldable (2023), 1 descendant of its own
- K240424: Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix (2024), 0 descendants of its own

## Indications for use
Mineral Collagen Composite Bioactive Moldable combined with either autogenous bone marrow or autograft with saline is indicated for bony voids or gaps, that are not intrinsic to the stability of the bony structure; Mineral Collagen Composite Bioactive Moldable can also be used with autograft as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., 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.

Source page: https://510kreport.com/device/K182074
Methodology: https://510kreport.com/methodology