(224 days)
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.
Norian Craniofacial Repair System (Norian CRS) is a paste-like bone cement which is intended for the restoration or augmentation of bony contours in the craniofacial skeleton, such as burr hole voids and other cranial defects. Norian CRS is an injectable and moldable, biocompatible, bone coment. The Norian CRS Reactants Pack contains the two sterile components used in Norian CRS: Calcium Phosphate Powder and Sodium Phosphate Solution.
When the Reactants Pack is mixed, a smooth, viscous paste is applied directly to the opcrative site, where it hardens in about 10 minutes to provide initial structural support. Within 24 hours, Norian CRS cures into a carbonated apatie that is similar to the mincral component of bone. The compresssive strength of Norian CRS is approximately 50MPa. Over time, Norian CRS is gradually resorbed.
The Norian Mixer. Delivery Device, and Delivery Needles are used to mix and deliver the Norjan CRS to the operative site.
This document describes the Norian CRS (Craniofacial Repair System), a bone cement intended for filling craniofacial defects. The information provided outlines its technological characteristics, performance data, and regulatory approval.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Reported Device Performance |
|---|---|
| X-ray Diffraction - Setting Time | Set (initial hardening) occurs at about 10 minutes. |
| X-ray Diffraction - Reaction Completion | Reaction is greater than 90% complete by 24 hours. |
| X-ray Diffraction - Cured Material Composition | Cures to become an apatite of low crystalline order with no by-products present. |
| pH Value Determination - pH Range | pH range of Norian CRS is 6.0-8.0 (measured during and after setting). |
| Dimensional Verification - Dimensional Change | No significant dimensional changes ( |
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).