# K102018: Norian Reinforced, Norian Reinforced Fast Set Putty

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA Products, LLC
- Decided: Sep 23, 2010 after 66 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: 3 generations back to K873689 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K012589: Fast Set Putty, Synthes (Usa) (2002) Summary page 1.

## Indications for use
Norian Reinforced and Norian Reinforced Fast Set Putty are indicated for repairing or filling cranial defects and craniotomny cuts with a surface area no larger than 25 cm'. Norian Reinforced and Norian Reinforced Fast Set Putty are also indicated for the restoration or augmentation of bony contours of the cranial skeleton (including fronto-orbital areas) such as burr hole voids and other cranial defects.

Source page: https://510kreport.com/device/K102018
Methodology: https://510kreport.com/methodology