Cambridge Partial Knee

The Cambridge Partial Knee is a unicompartmental (single-compartment) knee replacement system designed for cemented fixation. It consists of a cobalt-chrome femoral component and a titanium baseplate with overmoulded polyethylene (UHMWPE with Vitamin E) meniscal insert, intended for partial knee arthroplasty in patients with single-compartment degenerative or post-traumatic disease.

The subject device uses a symmetrical femoral component (versus asymmetrical in the predicate), incorporates Vitamin E-stabilized UHMWPE instead of standard UHMWPE, has a different bearing locking mechanism, and shows slight variations in femoral anterior-posterior length. Both use identical tibial baseplate and femoral materials (Ti6Al4V and CoCrMo), cemented fixation, and cover similar size ranges with modular design.

ASTM F1340-17, ASTM F1800-19e1, ASTM F3210-22, ISO 14879-1:2020, and ISO 21536:2023 were used for fatigue testing of tibial trays, femoral components, and general knee prosthesis performance evaluation.

The Cambridge Partial Knee has identical indications for use and intended use as the predicate (TLC Unicompartmental Knee System, K212870), uses the same basic design principles and materials, and non-clinical testing demonstrates equivalent strength and performance. Minor design differences (bearing mechanism, femoral symmetry, Vitamin E-UHMWPE) do not raise different safety or effectiveness questions and are supported by comprehensive performance testing.