# K180121: Rafugen DBM

- Pathway: 510(k) (Traditional)
- Applicant: Cellumed Co., Ltd.
- Decided: Apr 11, 2018 after 85 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: 1 generation back to K051195 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051195: Grafton DBM, Osteotech, Inc. (2005) Summary page 4.

## Indications for use
Rafugen DBM is intended for use as a bone void filler in bony voids or gaps of the skeletal system (i.e., pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. Rafugen DBM is resorbed/remodeled and is replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K180121
Methodology: https://510kreport.com/methodology