# K011736: DRG Quickmix

- Pathway: 510(k) (Traditional)
- Applicant: Doctor'S Research Group, Inc.
- Decided: Jan 30, 2002 after 239 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: 4 generations back to K873689 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991398: Bonesource Hydroxyapatite Cement (Hac) Expanded Kit, Stryker Leibinger (1999) Summary page 2.

## Indications for use
QuickMix is indicated for use in mixing BoneSource® Hydroxyapatite Cement and sodium phosphate solution. BoneSource is indicated for use in the repair of neurosurgical burr holes, contiguous cramotomy cuts and other cranial defects with a surface area no larger than 25 cm? per defect, and for augmentation or restoration of bony contour in the craniofacial skeleton including the fronto-orbital maler and mental areas.

Source page: https://510kreport.com/device/K011736
Methodology: https://510kreport.com/methodology