Chondrofix Osteochondral Allograft Prospective Study

Knee cartilage injuries are a major cause of pain and functional impairment in young to
middle age adults and can lead to progressive joint degeneration. In response to challenges
with current cartilage repair options, Chondrofix Allograft was developed as an
off-the-shelf treatment option adding to the variety of cartilage reparation offerings.

This study is a multicenter, prospective, post-market clinical outcomes study designed to
assess the clinical outcomes of Chondrofix Allograft used in the treatment of both primary
and revision cartilage repair cases. Study design includes up to 6 qualified investigational
sites with 50 subjects enrolled across all centers during an 18 month enrollment period.
Study subjects will be followed postoperatively for 5 years. The Investigators who are
responsible for the conduct of this study in compliance with this protocol will be
orthopedic surgeons who are skilled in the techniques of articular cartilage repair.

Inclusion Criteria:

Generally, the following inclusion criteria must be met, however, this is not a complete
list.

- Male and non-pregnant female subjects between 18 and 70 years; subject must be
skeletally mature

- If female, subjects are not pregnant at time of surgery and do not plan on becoming
pregnant during the first 24 months of the study

- Up to two (2) cartilage lesion(s), each measuring less than 8 cm2, of the femoral
condyle or trochlear groove of the knee

- Localized knee pain unresponsive to conservative treatment (e.g., medication,
bracing, physical therapy) and/or previous surgical intervention

Exclusion Criteria:

Generally, if a potential participant meets any of the following criteria, they will not
be eligible for this study. Additionally, more criteria will be evaluated to confirm
eligibility as this list is not a complete list of criteria.

- Concurrent participation in another clinical trial

- Cartilage lesion location is such that the implanted graft(s) will not be adequately
shouldered

- Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral
compartment (i.e., > than ICRS Grade 2 on the opposing articular surface)

- Is receiving pain medication other than NSAIDs or acetaminophen for conditions
unrelated to the index knee condition

- Subject had any other cartilage repair procedure other than debridement performed in
conjunction with or 6 months prior to implantation of a Chondrofix Osteochondral
Allograft

- Prior or concurrent total meniscectomy of the index knee

- Uncorrected mal-alignment of the index knee

- Have smoked or used nicotine products within the past 6 months

- Body Mass Index > 35 (BMI=kg/m2)

- Has any contraindications for MRI

- Requires any of the following concomitant procedures performed in conjunction with or
has had performed within 6 months prior to implantation of a Chondrofix Allograft:
distal realignment, high tibial osteotomy, ligament reconstruction, and/or patellar
realignment procedure

- Septic or reactive arthritis or systemic disease (e.g., rheumatoid arthritis, gout or
prior history of gout or pseudo gout)

- Sickle cell disease, hemochromatosis, or autoimmune disease

- Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer
or uncontrolled diabetes

- HIV or other immune-deficient state including subject on immunosuppressant therapies

- Deficiency limiting ability to perform an objective functional assessment of the
operative knee or an inability to adhere to a post-operative rehabilitation protocol