Small Bone Innovations has a Humanitarian Device Exemption (HDE) from the FDA to market or SR™MCP and SR™PIP Finger Joint Implants as Humanitarian Use Devices (HUD). An HUD is a device that is intended to benefit patients by treating a disease or condition that affects fewer than 4,000 individuals in the United States per year. SBi acquired this HDE with the acquisition of Avanta Orthopaedics.

A Humanitarian Use Device (HUD) is a legally marketed device. However, an HUD may only be used in facilities that have established a local institutional review board (IRB) and after an IRB has approved the use of the device to treat or diagnose the specific disease.

IRB approval must be obtained prior to SBi distributing this product to a physician. We must receive a copy of a letter from the IRB at the institution where the surgeon intends to perform surgeries granting approval for the physician to use this Humanitarian Use Device.

A simple letter from the local IRB to the treating physician approving the use of the device should at a minimum contain the following information:

1. Hospital name, address, telephone number;
2. Doctor's name and address
3. A statement that the IRB has reviewed and is approving the use of the Proximal Interphalangeal Joint (H980002) or Metacarpophalangeal Joint (H010001) for the approved indications;
4. Signature of the IRB chairperson.

Humanitarian Device Exemption Information –

http://www.fda.gov/MedicalDevices/...default.htm

• H980002, 28-Sep-98 Avanta Proximal Interphalangeal (PIP) Finger Prosthesis,
• H010001 28-Aug-01 Avanta Metacarpophalangeal (MCP) Finger Prosthesis.

HDE Regulation Questions and Answers
http://www.fda.gov/MedicalDevices/...ucm110194.htm