# K221735: Mineral Collagen Composite Bioactive Moldable

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Dec 20, 2022 after 188 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: 10 generations back to K960978 (1996). 50 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K182074: Mineral Collagen Composite Bioactive Moldable, Collagen Matrix, Inc. (2019) Summary page 4.

## Most influential descendants
- 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 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.c., the extremities, pelvis, 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. For spine application Mineral Collagen Composite Bioactive Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.

Source page: https://510kreport.com/device/K221735
Methodology: https://510kreport.com/methodology