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Knee Benchmarks

 

In accordance with ODEP’s basic premise of encouraging manufacturers to look at all available data in assessing the performance of products, ODEP expanded the benchmarking of medical devices to include total knee implants in 2015.

Whilst the benchmarks for hip implants are assessed at component level (cup or stem), ODEP knee benchmarks are provided at the construct level i.e. the assessment is made on the single unit implanted, as such, an individual brand will have multiple benchmarks. 

A separate submission is required for each knee construct, with the potential age of the implant unit being determined by the age of the most recent component and any change resulting in the submission being considered as a separate construct, as highlighted in the table below.

Femoral component Tibial component Insert Patella Age of construct Construct variant number
Fem 123 (CE marked for 11 years) Tib 123 (CE marked for 11 years) Ins 123 (CE marked for 11 years) Pat 123 (CE marked for 11 years) 11 years 1
Fem 123 (CE marked for 11 years) Tib 123 (CE marked for 11 years) Ins 456 (CE marked for 5 years) Pat 123 (CE marked for 11 years) 5 years 2
Fem 123 (CE marked for 11 years) Tib 123 (CE marked for 11 years) Ins 456 (CE marked for 5 years) No patella 5 years 3


At present, ODEP do not provide benchmarks for unicondylar knee replacements, patella femoral knee replacements or other partial knee replacements, however, this continues to be under review.

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