ORTHOSPACE

The InSpace™ balloon system is designed to create a physical barrier (spacer) between tissues in the subacromial space.

• The InSpace™ balloon system is provided sterile.
• The physiological solution that should be used with the InSpace™ balloon system is not supplied with the system.
• The InSpace™ balloon is latex and Phthalate free.

INDICATIONS

The InSpace™ biodegradable balloon implant is used as a spacer to reduce friction between the acromion and humeral head
or Rotator Cuff. The indications for the InSpace™ Rotator Cuff Balloon include: scarred or torn tendons due to trauma or
degradation; absence of tendon/muscle, or non-functional tendon/muscle; and ruptured tendon. The device is single use and
biodegrades within 12 month.

CONTRAINDICATIONS

• The InSpace™ balloon Implant should not be implanted into areas with active or latent infection or signs of tissue necrosis.
• The InSpace™ balloon Implant should not be implanted if the patient has an allergy to the balloon material (PLA and
  epsilon-caprolactone).

WARNINGS AND PRECAUTIONS

• Prior to using the InSpace™ balloon system for the first time, users must be trained by a company representative in the use and
  deployment of the balloon system.
• The risks and benefits of implanting the InSpace™ balloon system in patients with blood coagulation disorders, compromised
  immune systems, severe chronic diseases such as heart failure, cirrhosis, chronic renal failure or any other conditions that would
  compromise healing should be carefully considered.
• The risks and benefits of implanting the InSpace™ spacer in patients with deltoid palsy should be carefully considered.
• Do not re-sterilize or reuse the balloon or the deployer. All parts of the system are intended for single use only.
• Reuse of the system may cause serious injury to the patient, including but not limited to: local and systemic infection and sepsis
  that may lead to deterioration of shoulder functions or death.
• Non-functional instruments should not be used and should be returned to OrthoSpace Ltd. Do not use any part of the InSpace™
  balloon system beyond the indicated expiration date.
• Do not use the InSpace™ balloon system if the package is opened or damaged, as sterility may be compromised.
• Do not use the InSpace™ balloon system if the Humidity Indicator for the 40% humidity level has turned from a light blue
  to a purple color.

STORAGE

Until use, the Orthospace™ balloon system should be stored in a clean and dry area at 0-29°C.