# K171629: ABCcolla Bone Graft

- Pathway: 510(k) (Traditional)
- Applicant: Acro Biomedical Co., Ltd.
- Decided: Feb 1, 2018 after 244 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: 4 generations back to K990131 (1999). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090401: Orthoss, Ed. Geistlich Soehne AG Fur Chemische Industrie (2010) Summary page 4.
- K110949: Bicera (TM) Resorbable Bone Substitute, Wiltrom Corporation Limited (2012) Summary page 4.

## Most influential descendants
- K212156: ABCcolla Bone Matrix (2021), 0 descendants of its own

## Indications for use
ABCcolla® Bone Graft is an implant intended to fill bony voids or gaps of the 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 the bony structure. ABCcolla® Bone Graft resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K171629
Methodology: https://510kreport.com/methodology