Product Classification

• 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 Code: PIX
• Premarket Review: Office of Orthopedic Devices (OHT6); Joint Arthroplasty Devices (DHT6A)
• Not Classified Reason: For Export Only
• Submission Type: Contact ODE
• Device Class: Not Classified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 11-404 ASTM F2887-23
  Standard Specification for Total Elbow Prostheses

Third Party Review

Not Third Party Eligible