# K023718: Quickset Mimix Bone Void Filler

- Pathway: 510(k) (Special)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Dec 4, 2002 after 29 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: 1 generation back to K990290 (1999). 1 ancestor in all.
43 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990290: Craniofacial Calcium Phosphate Ceramic Bone Filler, Biomet, Inc. (1999) Summary page 1.

## Most influential descendants
- K032366: Bonesource Hac Fast Setting Cement (2003), 41 descendants of its own
- K043334: Bone Source Hac Rapid Setting Cement (2005), 36 descendants of its own
- K060061: Stryker Injectable Cement (2006), 30 descendants of its own
- K161447: HydroSet XT (2016), 10 descendants of its own
- K060763: Stryker Injectable Cement (2006), 8 descendants of its own

## Indications for use
The QuickSet Mimix™ Bone Void Filler is a self-setting calcium phosphate cement indicated for the following craniofacial procedures: 1. Repair of neurosurgical burr holes 2. Craniotomy cuts and other cranial defects 3. Augmentation or restoration of bony contour in the craniofacial skeleton area no larger that 25 cm2

Source page: https://510kreport.com/device/K023718
Methodology: https://510kreport.com/methodology