Medical polycarbonate, coloring capabilities fulfill intelligent medical device requirements
Just what the doctor ordered
When designing a new device for orthopedic surgery, OrthoSensorTM sought a thermoplastic material that offered biocompatibility, superior strength, quick release from the mold, as well as easy colorability.
Makrolon® Rx1851 polycarbonate was just what the doctor ordered for the OrthoSensor™ Balancer, providing improved flow, lubricity, easy release and strength, as well as compliance with FDA-modified 10993, Part 1.
Knee Balancer orthopedic device
Product: Makrolon® Rx 1851
Covestro’s custom color technologies
Makrolon® Rx1851 polycarbonate was just what the doctor ordered for the Knee BalancerTMOrthoSensor. Not only does this medical grade of resin offer improved flow, lubricity, easy release and strength, it is also compliant with FDA-modified 10993, Part 1.
The OrthoSensor Knee Balancer is a revolutionary, intelligent orthopedic device, so using a high-quality, reliable material was of paramount importance to OrthoSensor.
The device uses sensors and wireless technology to provide real-time, evidenced-based data to the surgeon to optimize the positioning and balance of implants. By giving surgeons the ability to quantify adjustments intraoperatively, the device contributes to improved patient comfort and prosthetic longevity.
Another important aspect of this project was Covestro’s ability to provide custom color formulations for its biocompatible grades of Makrolon®. The intelligent device is available in four transparent colors – brown, green, blue and yellow – each color-matched to its specifications and each indicating a specific surgical size. The devices can also be used with four shim sizes that correspond to these colors, which increase the thickness of the device, allowing for variations in patient anatomy.
During development, Covestro worked with the molder to safeguard the integrity of the material and assure that OrthoSensor’s high standards were met.
The main properties of Makrolon® Rx1851 polycarbonate are:
- High impact strength
- Able to be sterilized
- Satisfies major bio-compatibility requirements
- Resistant to many pharmaceuticals
- Custom colorability