# K212156: ABCcolla Bone Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Acro Biomedical Co., Ltd.
- Decided: Oct 8, 2021 after 88 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 K990131 (1999). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171629: ABCcolla Bone Graft, Acro Biomedical Co., Ltd. (2018) Summary page 4.

## Indications for use
ABCcolla® Bone Matrix is intended to fill bony voids or gaps of skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of bone structure. ABCcolla® Bone Matrix provides resorbs and is replaced by bone during the healing process.

Source page: https://510kreport.com/device/K212156
Methodology: https://510kreport.com/methodology