# K182742: DB-CMF

- Pathway: 510(k) (Traditional)
- Applicant: Dimensional Bioceramics, LLC
- Decided: Jun 20, 2019 after 265 days
- Product code: GXP (Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- 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 K873689 (1987). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162864: OsteoVation Impact, Skeletal Kinetics, LLC (2017) Summary page 4.

## Indications for use
DB-Cranial is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes or other cranial bone defects and craniotomy cuts with a surface area no larger than 25 cm2. DB-Cranial may be used in the restoration or augmentation of bony contours of the cranial bone skeleton.

Source page: https://510kreport.com/device/K182742
Methodology: https://510kreport.com/methodology