LIMA CORPORATE Awarded New ODEP Ratings

By Julie A. Vetalice

Lima Corporate was awarded three new Orthopaedic Data Evaluation Panel (ODEP) ratings for hip implants in the U.K. The ratings are intended to indicate that a device's clinical performance falls in line with National Institute for Health and Care Excellence (NICE) guidelines for survivorship of total hip replacements.

Lima's updated ratings are:

  • Delta PF Primary Uncemented Acetabular Cup, 10A
  • Modulus Complex Primary Femoral Stem, 10A
  • H-Max S Primary Uncemented Femoral Stem, 5A

The company previously received a 5A* ODEP rating for the Delta TT Primary Uncemented Acetabular Cup and the C2 Primary Uncemented Femoral Stem.

Source: Lima Corporate

The Orthopaedic Data Evaluation Panel was established in the U.K. in 2002 to monitor NICE guidance on primary hip implants and later, hip resurfacing. ODEP ratings are provided at benchmarks of three, five, seven and ten years of follow-up, with an A*, A or B rating based on strength of evidence and quality of data provided by a manufacturer. Main criteria are survivorship of implants, number of patients and length of follow-up. Ex-U.K. countries use ODEP ratings to assist in approval of products into the marketplace.

 

 

Product Labels: Hip Replacement

Tags: Regulatory