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U.S. Department of Health and Human Services

Product Classification

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Device transfemoral percutaneous prosthetic
Definition The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb.
Physical State the device may be threaded, or coated to provide fixation to the bone. The device is made from medical grade mettalic components.
Technical Method The device is implanted into the femur to allow a fixation point for standard prosthetic limbs.
Target Area Femur of amputee patients
Review Panel Orthopedic
Product CodePJY
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
Submission Type HDE - Humanitarian Device Exemption
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible