Indications

• Suitable for the fixation of soft tissues and bone in the shoulder, foot and ankle, elbow, knee, and hip joints.

Contraindication

• Insufficient bone quality or quantity, inadequate blood supply, or comminuted bone surfaces that may compromise implant stability

• Pathological bone changes that may affect implant stability, such as cystic bone or severe osteoporosis

• Medical conditions that interfere with or are likely to interfere with proper implant stability or delay healing, such as inadequate blood supply, active or past infections, etc.

• Allergy to implant materials. If a material allergy is suspected, appropriate testing should be conducted to rule out the possibility of an allergic reaction prior to implantation.

• Factors such as advanced age, mental illness, or alcohol abuse that may affect a patient’s ability or willingness to restrict activities or follow medical instructions during treatment

• This device is not intended for use in patients with insufficient bone mass or immature bones; prior to performing orthopedic surgery on patients whose bones have not yet fully matured, the physician should carefully assess bone quality;

• The use of this device and the placement of the implant must not bridge, obstruct, or damage the growth plate.

• Pathological changes in the affected soft tissues may interfere with proper fixation

• The implant is not designed for, nor should it be used to connect to, artificial ligaments or other implants.

• Surgeries other than those listed in the Indications section