This product is a collagen-based tissue supplement with a dense paste consistency, composed of human tissue cartilage particles and HA-CMC, a hydrogel-type additive, physically mixed together. The human tissue cartilage particles contain collagen components, while the HA-CMC additive plays a role in maintaining the formulation. This product functions as a physical covering after microfracture surgery for localized knee cartilage defects, preventing the loss of blood clots and supporting the positioning of autologous bone marrow-derived stem cells.

1) Collagen-based Tissue Supplement: This product is used for the treatment of cartilage defects in the knee joint. It acts as a physical covering during microfracture surgery to prevent the loss of blood clots, supporting cartilage regeneration. It is a collagen-containing substance utilized in the treatment of cartilage defects.

2) Injection Device: It is used as a supplementary tool for administering MegaCarti into the defect area.

1)Room temperature (1~30 ℃)

2)Direct sunlight and high temperature or humid conditions should be avoided.

3)Shelf Life: 2years

A. Precautions related to age, gender, or health conditions considering the characteristics of the medical device

1) The product should not be used if the patient has an infectious disease or if there is a possibility of a hypersensitive reaction to the implant.

B. Notices regarding adverse events after use of medical device, deadly side effects or accidents due to careless handling

1) If the opened product has been left in a contaminated or non-sterile condition before implantation, it should not be implanted in the patient. Instead, contact L&C Bio for a return process or properly dispose of it as medical waste.

2) Before use, confirm that the patient does not have an allergic reaction to the reagents or solutions used during the manufacturing process of the product.

3) The product should be used within the expiration date indicated on the product label. If the product has expired, contact L&C Bio for a return or exchange.

4) The product should be stored in a cool, dry place away from direct sunlight, following the recommended storage methods.

C. General precautions

1) Before using this product, read all instructions and precautions carefully. Failure to follow the instructions may result in the product not performing as intended, or it may lead to infections or adverse reactions.

2) This product is intended for treatment by professional medical personnel only and should not be used for purposes other than its intended use.

3) If the packaging is found to be damaged or compromised before use, the product should not be implanted. Contact L&C Bio immediately for a return or exchange.

4) If any adverse reactions are observed in a patient who received the implant, report to the Ministry of Food and Drug Safety (MFDS) immediately, and the hospital and doctor responsible for the implantation should provide the necessary medical care.

D. Use for pregnant women, lactating women, childbearing women, newborns, infants, children, the elderly

1)Although no pregnancy-related adverse events were observed in women of childbearing age included in clinical trials, continuous monitoring and caution are required when using this product in women of childbearing age.

2)There is no clinical data on the use of this product in pregnant or breastfeeding women. Therefore, it should not be used for safety reasons.

3)Clinical trials have not been conducted to assess the safety and efficacy of this product in newborns, infants, or children. Therefore, it should not be used in these populations.

E. Application precautions

1) The product is gamma-ray sterilized and should not be re-sterilized, and even once opened, the product should not be re-sterilized and reused.

2) Each product is intended for use on only one patient.

F. Notices to prevent negligent accident

1) Since this product is manufactured through a GMP process certified by the Ministry of Food and Drug Safety, it is recommended to use this product in an appropriate environment (clean room or operating room) and facility similar to the manufacturing environment.

2) When using the product, be careful not to contaminate the affected area or the treated area.