Calypso Knee System Clinical Study

Prospective, multicenter clinical study of the Calypso Knee System. 80 subjects will be
enrolled in this study at up to 10 investigational sites located in the U.S. Male or female
subjects age 25 to 65 years, with a diagnosis of medial knee osteoarthritis and study knee
pain with an overall WOMAC pain score ≥ 40 (scale 0-100).

Inclusion Criteria:

1. Participants age - 25 to 65 years

2. Body Mass Index (BMI) of < 35, Weight < 300 lbs

3. Knee osteoarthritis pain on the inner side of knee that has continued after at least 6
months of non-operative treatment

Exclusion Criteria:

1. Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral
compartments of the target knee

2. Knee ligament or meniscal instability

3. Other bone or joint conditions such as Rheumatoid arthritis, Paget's disease,
Charcot's disease or general conditions such as allergy or hypersensitivity to certain
metals, active infection, certain neurological conditions, use of medication such as
steroids or chemotherapy that could impact study participation or results