R3 Delta Ceramic Hip System

FDA premarket approval P150030 · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

PMA numberP150030

Approval

Applicant
Smith & Nephew, Inc.
Received
August 20, 2015
Decision date
October 17, 2016 (APWD)
Supplements
48, latest April 17, 2025
Product code
MRA – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

Official FDA PMA record

Approval order statement

Approval for the R3TM delta Ceramic Acetabular System. This device is indicated for use in skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.