Valid from 31 July 2023

Click here to download the current ODEP Wrist criteria (PDF)

ODEP welcomes submissions for Total Wrist Replacements, Wrist Hemi-Arthroplasties and Wrist Spacers. The ODEP rating applies to the construct as a whole rather than to individual components. A construct represents a unique combination of components (or catalogue numbers) that together form the implanted device.

What constitutes a construct?

A Total Wrist Replacement construct is defined by the specific combination of radial (or distal radius) component, carpal component, and any associated bearing or articulating insert. Each unique combination of these elements is treated as a separate construct for the purposes of ODEP rating.

What must be identical across a construct?

For components to be grouped within a single construct, the following characteristics must be identical:

Radial Component

• Material composition (e.g. cobalt chrome, titanium alloy)
• Surface finish and coating (e.g. hydroxyapatite, porous coating, plasma spray, uncoated)
• Fixation philosophy (e.g. stemmed, press-fit, screw-fixed)
• Method of fixation (cemented vs. uncemented)

Carpal Component

• Material composition
• Surface finish and coating
• Fixation philosophy (e.g. screw fixation into carpus, press-fit, stemmed)
• Method of fixation (cemented vs. uncemented)

Bearing / Articulating Surface

• Bearing type and articulation (e.g. metal-on-polyethylene, metal-on-metal, pyrocarbon)
• Polyethylene type where applicable (e.g. conventional UHMWPE, highly cross-linked polyethylene)

Bearing surface distinctions

Where an implant system offers more than one type of bearing surface, each bearing configuration must be assessed separately and will receive its own ODEP rating based on survival data that relates specifically to that bearing surface. For example, if a manufacturer supplies both a metal-on-metal bearing and a metal-on-polyethylene bearing, each would receive its own ODEP rating provided that sufficient data were submitted for each. If a bearing type lacks sufficient data, it will not be awarded an ODEP rating.

Size variations

Different sizes within the same component design family do not constitute separate constructs, provided all other characteristics listed above remain identical. However, where a manufacturer markets a distinct sub-range with a different geometry or design philosophy (not simply a scaled version of the standard component), this shall be treated as a separate construct.

Wrist Hemi-Arthroplasties and Wrist Spacers are assessed as distinct implant categories. In each case, the product definition principles set out above apply: the construct is defined by the combination of implanted components, and the characteristics that must be identical (material composition, surface finish, fixation philosophy, bearing surface, and method of fixation) apply in the same manner.

The benchmark criteria for wrist constructs follow the standard ODEP rating framework. The assessment criteria have been adapted from the methodologies used for other joints, informed by a literature review of the best available evidence specific to wrist arthroplasty.

The ODEP rating for a wrist construct is determined by the rating achievable by the most recently introduced component within that construct.

The methodology described above will be reviewed periodically in line with standard ODEP practice. There are regular opportunities for manufacturers to submit data for assessment by the Panel and dates are advertised through the ODEP website – Events.