FDA Approves IDE Study of BioPoly RS Partial Resurfacing Knee

By Julie A. Vetalice

BioPoly received FDA approval to conduct an Investigational Device Exemption clinical study of the BioPoly® RS Partial Resurfacing Knee, used in the treatment of cartilage lesions.

BioPoly material combines polymer and hyaluronic acid into a “self-lubricated” polymer that can carry physiological loads without causing damage to other knee tissues, acting as a synthetic cartilage. The system has been implanted successfully in Europe since 2012; in 2016, it received CE Mark approval for use in the shoulder, followed in 2018 for repair of the trochlea.

The company is also developing additional applications in the knee, foot/ankle, upper extremity and hip.

Source: BioPoly LLC

Product Labels: Knee Replacement

Tags: Regulatory