Product Classification

• Device: prosthesis, shoulder, semi-constrained, metal/polymer, uncemented
• Regulation Description: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
• Regulation Medical Specialty: Orthopedic
• Review Panel: Orthopedic
• Product Code: MBF
• Submission Type: 510(k)
• Regulation Number: 888.3670
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 13779-1:2008(E) Implants for surgery - Hydroxyapatite - Part 1: Ceramic hydroxyapatite
• ISO 13779-2:2008(E) Implants for surgery - Hydroxyapatite - Part 2: Coatings of hydroxyapatite
• ASTM F 983-86 (Reapproved 2009) Standard Practice for Permanent Marking of Orthopaedic Implant Components
• ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• ASTM F2024-10 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
• ASTM F732-00 (Reapproved 2011) Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

Guidance Document

• Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis

Third Party Review

Not Third Party Eligible