# K973789: Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System (CRS) Bone Cement- 10CC

- Pathway: 510(k) (Traditional)
- Applicant: Norian Corp.
- Decided: May 18, 1998 after 224 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: 2 generations back to K873689 (1987). 5 ancestors in all.
49 later devices descend from it; 4 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953339: Bonesource Hydroxyapatite Cement (Hac), Osteogenics, Inc. (1996). Our OCR of the scanned summary read K953333, FDA’s number for Menstrual Tampon (Paragon Trade Brands, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Osteogenics BoneSource® Hydroxyapatite Cement”. Summary page 2.
- K964537: Bonesource Hydroxyapatite Cement (Hac), Osteogenics, Inc. (1997) Summary page 1.
- K970400: Bone Source Hydroxyapatite, Orthofix, Inc. (1997) Summary page 1.

## Most influential descendants
- K991398: Bonesource Hydroxyapatite Cement (Hac) Expanded Kit (1999), 45 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
- K060061: Stryker Injectable Cement (2006), 30 descendants of its own

## Indications for use
Norian CRS 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 25cm².

Source page: https://510kreport.com/device/K973789
Methodology: https://510kreport.com/methodology