Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System

Exclusion Criteria

• •Amputation \< 6 months prior to enrollment
• •Residual limb less than (\<) 26cm and greater than (\>) 34cm circumference at the distal end.
• •Body weight greater than (\>) 275lbs.
• •Syme's amputations or total limb length over 30cm
• •Some bulbous or irregular limb shapes
• •Build height and circumference limitations
• •Wounds or skin issues that preclude normal fit
• •Unusual alignment of the socket or foot
• •Alignment outside the capability of the Xtremity System.
• •Planned for any major surgery within 6 months of enrollment.
• •Subject is pregnant or breastfeeding
• •Subject is incarcerated.
• •Subject anticipates that the socket will frequently be subject to temperatures greater than 110 degrees F while in their possession.
• •Subject anticipates that the socket will frequently be subject to direct sunlight
• •Limb circumference at the mid-patella tendon exceeds the maximum circumference (see sizing chart in the instructions for use)
• •Subject is participating in another research study of a device, medication, which could, in the opinion of the investigator, affect the results of this study.
• •Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and or participating in evaluations pre and post-treatment.