Device Dossier
Knee femur trial prosthesis
Device Dossier for Knee femur trial prosthesis (Knee femur trial prosthesis, Class IIa, sponsor Stryker). ARTG record, intended purpose, GMDN category —…
- GMDN category: Knee femur trial prosthesis
- Sponsor: Stryker
Intended purpose
Surgical instrument intended for use during knee arthroplasty, or trauma surgeries, to evaluate the patient’s joint surface anatomy following bone preparation and facilitate the physician’s determination of approximate implant size for the corresponding total joint replacement component. Several trial components may also be used concurrently to ensure proper joint ligamentous balance and range of motion prior to device implantation.