Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration

The Cartilage Autograft Implantation System (CAIS) is a kit of devices that utilizes
morselized autologous hyaline cartilage harvested arthroscopically, affixed onto a
synthetic, resorbable implant using a fibrin sealant and implanted in a single surgical
procedure. The system is designed as a surgical treatment of damaged knee cartilage using
the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region.

Inclusion Criteria:

- A male or female 18 to 55 years of age,

- Has 1 or 2 focal chondral lesions, that require repair, per index knee presenting
with moderate to severe knee pain. Each lesion is ≤6 mm in depth and has an area of
≥1 cm2 and ≤10 cm2. Arthroscopic confirmation indicates that the lesions are either
a non-OCD lesion between grades I and III (D) or an OCD lesion between grades I and
IV(A)

- Prior failed chondral treatment is allowed if the procedure occurred > 6 months for
debridement and lavage or > 1 year for marrow stimulation techniques.

Exclusion Criteria:

- Have more than 2 chondral lesions on the index knee,

- Bipolar lesions on the index knee,

- Greater than 5 degrees of malalignment,

- Require bilateral surgery

- Have a diagnosis of clinical and/or radiographic disease of the index joint.