Stanmore Implants has received the US Food and Drug Administration (FDA) 510k approval for its Juvenile Tumour System (JTS) non-invasive extendible distal femoral replacement (JTS implant) which is used in paediatric orthopaedic oncology surgery.
JTS implant is used to replace large sections of the distal femur (thigh bone) that has been removed during surgery, often to treat cancer.
The JTS implant uses an electromagnetic device so as to lengthen the prosthesis without the need for surgery, anaesthesia or sedation in order to reduce the risk of complications.
Stanmore executive chairman Brian Steer said having used the product for nine years in the European markets they are confident of the product’s ability to improve patient outcomes and quality of life by negating the need for repeated surgery in children.
Stanmore Implants designs and manufactures both bespoke and modular implants for limb sparing and complex primary and revision joint replacement.