# K990290: Craniofacial Calcium Phosphate Ceramic Bone Filler

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Nov 18, 1999 after 293 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.
50 later devices descend from it; 5 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K012569: Modification to: Injectable Mimix (2001), 45 descendants of its own
- K023718: Quickset Mimix Bone Void Filler (2002), 43 descendants of its own
- 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

## Indications for use
The Craniofacial Calcium Phosphate Ceramic Bone Filler is a self-setting calcium phosphate cement intended for the 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.

Source page: https://510kreport.com/device/K990290
Methodology: https://510kreport.com/methodology