The device is intended to retract, stabilise and approximate tissue during orthopaedic procedures on the lower arm. The system is made of an X-ray transparent plastic material and thus can be left in place during intraoperative fluoroscopic use. Modular system consists of several specific instruments. Due the elasticity of the material, the shape of the individual instruments can adapt in the course of the retraction process. This is a desired effect that leads to better attachment of the retractor to the tissue, which thus helps to reduce tissue damage, while optimizing the surgeon’s view of the surgical field.
Full design of the product, additional innovative features and functionalities were implemented.
Set of molded, adjustable to human anatomy components was introduced. Additional features, such as easy and intuitive mounting were implemented.
The system is a made of polyethylene copolymer (CAS No. 25087-34-7, with 1-butene as comonomer). It does not contain any substance classified as hazardous per the EC directives.
- Defining requirements (CAD labs)
- 3D printed and vacuum casted prototypes
- Participation in anatomy workshop – testing & verifying functionality
- 3D & 2D drawings
- Engineering calculations
- Molding tools
- Validations (molding, sterilization, shelf-life, package design)
- Vendor & BOM management
- CE marking
Typical areas of aplication:
orthopaedic surgical devices.