# K060445: Norian CRS Bone Cement

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 13, 2006 after 51 days
- Product code: GXP (Methyl Methacrylate For Cranioplasty)
- Device class: 2
- Regulation: 21 CFR 882.5300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K873689 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973789: Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System (CRS) Bone Cement- 10CC, Norian Corp. (1998) Summary page 1.

## Recalls of this device
- Sep 14, 2009 · Not classified · Z-0269-2010: Non-conforming material - increased set time. Potential clinical ramifications associated with increased set time and decreased strength include extrusion of unset material and fragmentation of cured 

## Indications for use
Norian CRS Bone Cement is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm 2.

Source page: https://510kreport.com/device/K060445
Methodology: https://510kreport.com/methodology