# K012569: Modification to: Injectable Mimix

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Dec 21, 2001 after 134 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.
45 later devices descend from it; 2 cite it directly.
0 of 47 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
- K021440: Bonesource Hac (2002), 43 descendants of its own
- 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

## Indications for use
The Injectable Mimix™ is a self-setting calcium phosphate cement intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. The bone filler is not intended for percutaneous injection use.

Source page: https://510kreport.com/device/K012569
Methodology: https://510kreport.com/methodology