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Introducing ODEP

ODEP is the Orthopaedic Data Evaluation Panel, an independent panel of clinical and non-clinical experts with experience of the orthopaedic industry.  The Panel was set up in 2002 by NHS Purchasing and Supply Agency in response to the National Institute for Health and Care Excellence (NICE) issuing guidance relating to total hip replacement and resurfacing arthroplasty for end stage arthritis of the hip.

ODEP provides objective, systematic ratings of the strength of evidence supporting the performance of an orthopaedic implant. The evidence is provided by the implant manufacturer and assessed by ODEP against a set of benchmarks.  ODEP does not make recommendations about the use of one implant in preference to another but assesses the quality of evidence a manufacturer provides and determines if it reaches the relevant performance benchmarks.

Following the award of a CE / UKCA mark, the manufacturer of an orthopaedic implant is able to apply for a “Pre-entry level” ODEP rating.  At agreed future time-points, based on previously observed implant failure patterns, the manufacturer then has to submit their evidence data at 3, 5, 7, 10, 13 and 15 years in order to achieve and then retain their ODEP Rating.

Originally created for hip implants, ODEP continues to evolve, and has since developed benchmarks for Knee replacements  in 2014,  Shoulder replacements in 2017, Elbow replacements in 2020 and Spinal replacements in 2022.

What Products are ODEP rated?

ODEP provides ratings for:

  • Hip Replacements including surface replacements. Femoral components and acetabular components are rated separately. (Please see Hips under the section on methodology for more information)
  • Knee replacement implants including Total Knee replacements (TKRs) and uni-condylar knee replacements (please refer to the knee section in methodology for more detailed information)
  • Shoulder replacements including “Reversed”, anatomic, resurfacing, glenoid replacements and trauma implants.
  • Elbow replacement implants including Total (TERs), distal humeral and radial head replacements.
  • Spinal implants – currently cervical discs only.
  • Wrist replacement implants including Total Wrist Replacements, Hemi-Arthroplasty and Spacers.
  • Ankle replacement implants – Total Ankle Replacements and Total Talus Replacements

In the case of knees, shoulders, wrists and ankles ODEP ratings apply to constructs rather than by individual components.  A construct represents a unique combination of components (or catalogue numbers). Thus, ODEP may provide one rating for a Total Knee Replacement in which the patella is resurfaced and a different one where it is not. Ratings may be different to reflect the variety of surface coatings for a hip system within the same “brand”, or the different treatments applied to the polyethylene used in a tibial insert. 

The ODEP rating for a knee replacement is the rating for the most recently introduced part of the construct. Thus, if the femoral component would have qualified for 13A* but the tibial tray demonstrates the survival and follow-up data for 3A, the rating of this construct will be 3A. Some brands have over 40 separate ODEP ratings ranging from Pre-Entry to 15A*.


ODEP and Beyond Compliance are developing systems for benchmarking various types of spinal implants and the introduction of new devices.

For ODEP for spinal implants the basic ODEP philosophy will remain the same which means that manufacturers of spinal devices will have to collect data to be validated independently for their implant to have an ODEP rating

The ODEP Method

The ODEP method has been specifically designed to maximise patient safety whilst recognising the need to support innovation. ODEP has two special categories for devices that have had insufficient use in the UK to support 3 years of evidence. The first is “Pre-entry”. This is not a benchmark rating.  Rather, it is where the manufacturer has obtained their UKCA/CE mark and has registered the implant with ODEP (in the expectation of applying for a benchmark rating at a future date).   The second category is “Pre-entry A*”. This is a benchmark rating that indicates that the device has achieved its UKCA/CE mark and is also going through the Beyond Compliance* process

This approach aims to help hospitals provide safe and effective care whilst also providing a means of continuous improvement.


*Beyond Compliance is a voluntary service evaluation programme manufacturers can elect to enter for their new or modified  orthopaedic implant, which closely monitors its performance during the early years of use, where data alone may provide insufficient evidence of safe use and closer engagement with implanting surgeons is also required.