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U.S. Department of Health and Human Services

Product Classification

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Device elbow joint metal/polymer, constrained, porous coated, uncemented prosthesis
Definition An elbow joint metal/polymer constrained uncemented prosthesis is a device intended to be implanted to replace an elbow joint.
Physical State The components have a porous coating made of Ti-6Al-4V alloy powder. The coating is further enhanced by a layer of hydroxyapatite.
Technical Method The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. It is designed to achieve biological fixation to bone without the use of bone cement.
Target Area Elbow
Review Panel Orthopedic
Product CodePIX
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
Not Classified Reason For Export Only
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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