MSS - Clinical Investigation An Investigation of a New Manufacture Technique of a Trans-femoral Socket and Its Function for Amputees.

The investigation will be of a single group prospective pre/post design with follow up at 6 weeks (6WFU) and 6 months (6MFU); comparing to outcomes at baseline (BL).

Device(s) being tested: Interchangeably: Direct Socket TF; DS-TF; DS Trans-femoral.

The DS-TF is a trans-femoral (TF) set-up of the currently marketed trans-tibial version. It is not marketed in the USA and has not been registered with the FDA.

The comparator is the current socket the subject is using when enrolled in the study.

Subjects recruited: Minimum 50

Inclusion criteria:

50Kg< body weight < 160Kg Cognitive ability to understand all instructions and questionnaires in the study; Patients who have undergone a transfemoral amputation > 1 year post amputation Older than 18 years Willing and able to participate in the study and follow the protocol Circular dimension of 40-65 cm at the crotch Residual limb length at least 20 cm from ischium to distal end Currently using a prosthetic liner Locking users that can successfully be fitted with Iceross® Transfemoral Locking, OR Seal-In users that can successfully be fitted with either Iceross Seal-In® X5 TF or Iceross Transfemoral Seal-In®

Exclusion criteria: 50Kg> body weight > 160Kg Users with cognitive impairment Patients who have undergone a transfemoral amputation <1 year post amputation Younger than 18 years Not a prosthetic ambulator, uses only the prosthesis for cosmetic reasons Circular dimension of less than 40 cm or greater than 65 cm at the crotch Residual limb length less than 20 cm from ischium to distal end Currently not using a prosthetic liner