# K060443: Norian CRS Fast Set Putty

- 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K012589 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012589: Fast Set Putty, Synthes (Usa) (2002) Summary page 1.

## Indications for use
Norian CRS Fast Set Putty 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/K060443
Methodology: https://510kreport.com/methodology