# K043280: Mimix MP Bone Void Filler

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Dec 21, 2004 after 25 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K030290: Periolase  ND:Yag Dental Laser System, Millennium Dental Technologies, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Mimix TM MP 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 than 25cm 2.

Source page: https://510kreport.com/device/K043280
Methodology: https://510kreport.com/methodology