The AlloAid® IP is a sterile, engineered Allograft. The Allograft is supplied in 2 sizes featuring both straight & 10° angled configurations. The AlloAid® IP complies with all FDA, AATB and State Regulatory requirements for donor screening, recovery and testing.
The AlloAid® IP Allograft is designed with Positioning Ramps at the joint line to help accurately position the Implant and assure a press fit, and reduce the chance of subsidence. The cross-sectional shape and tapered design resists rotation. Tapered ends help with the ease of insertion.
KNOW YOUR PRODUCT SAL. The AlloAid® IP Allograft is terminally sterilized using a validated gamma irradiation process at an SAL (Sterility Assurance Level) of 10-6. This representation of SAL illustrates the occurrence of a living microorganism surviving the sterilization process. SAL 10-6 designates the probability of finding an unsterile product to be 1 in 1 million. Competitive tissue products may be sterilized to an SAL of 10-3. This increases the odds of finding an unsterile product to 1 in 1 thousand.
- Designed with Positioning Ramps to help accurately position the implant and assure a press-fit.
- Sterile allograft has conductive properties.
- No post-op hardware removal needed
- Available in both straight & 10° angled configurations.
- This allograft complies with all FDA, AATB and State Regulatory requirements for donor screening, recovery and testing.
INDICATION FOR USE
AlloAid® IP allograft is a Human Cellular and Tissue Based Product (HCT/P) per 21 CFR Part 1271. AlloAid® IP sterile machined cortical bone allografts are intended for transplant in small bone fusion procedures. Each allograft is restricted to homologous use for transplant in fusion surgical procedures on a single occasion by a licensed physician or surgeon.
WARNINGS AND PRECAUTIONS
An allograft may not elicit proper response from the recipient (e.g. fusion/union with adjacent tissue). It is possible for a host site to become infected. The allograft may not provide mechanical support and collapse, or may cause an inflammatory response. Current technologies may not preclude the transmission of infectious agents or disease, including hepatitis and HIV.
AlloAid® IP may contain trace amounts of one or more processing agents including iodine, ethanol, hydrogen peroxide, gentamicin and/or vancomycin. It should not be used in patients with sensitivities to these processing agents.
TRANSPORTATION, STORAGE AND HANDLING
AlloAid® IP is supplied ready to use and must be stored between 2°C and 40°C (36°F and 104°F) until prepared for use. It is the responsibility of the transplant facility or clinician to maintain the allograft intended for transplantation in the appropriate recommended storage conditions prior to transplant.
AlloAid® IP is provided sterile following an internationally recognized validation method and a proprietary irradiation system using gamma radiation to a Sterility Assurance Level of 10-6.
INSTRUCTIONS FOR USE
AlloAid® IP should not be used if:
- The expiration date shown on the labeling has passed,
- The packaging is damaged or compromised, or
- The recommended storage conditions have not been maintained.Do not re-sterilize or reuse once opened.
The inner bottle and allograft are sterile. The outer peel pouch is not sterile.
- Examine outer peel pouch. Do not use if there is evidence that the integrity of the outer pouch has been compromise
- Aseptically present the inner bottle onto a sterile field.
- Remove the safety seal band / cap.
- Remove the stopper of the bottle and pour the contents into a sterile preparation basin on the sterile field. The allograft is ready for use.
- The allograft must be used during the surgical procedure once opened. If opened and not implanted, the graft must not be re-sterilized and must be discarded.
The FDA requires traceability from the donor to the recipient. The physician is responsible for completing the recipient records to ensure traceability. As a convenience, pre-printed peel-off labels are included with each allograft. Using the labels, record the allograft tissue identification information in the patient medical record.
Dissection and Joint Preparation
A standard dorsolinear incision over the IP joint. Dissect soft tissue until the IP joint is exposed. Resect the middle phalanx and remove distal cartilage.
Middle Phalanx Preparation
Select the appropriate diameter Reamer and hold the Reamer at 90 degrees while keeping it central within the canal. Advance until the proximal line of the Reamer is flush with the bone surface.
Distal Phalanx Preparation
Hold Reamer at 90 degrees to the resected surface of the bone and keep it central within the canal. Advance until the distal line of the Reamer is flush with the bone surface. Remove the AlloAid® IP Allograft from the sterile package.
Insert proximally using provided Forceps. FIG. A taking care not to squeeze the Allograft. Holding the Allograft at the transition, FIG. B. Apply slow steady pressure until the Allograft is fully seated.
Manually reduce distal phalanx over the distal end of the AlloAid® IP Allograft until the distal phalanx is fully reduced. Reduce directly over the Implant, do not twist on.
Closure using surgeon preference
NOTE: The AlloAid® IP Allograft does not allow for the immediate resumption of activity by the patient. The surgeon must determine the length of time (approximately 6 weeks) required to accomplish a fusion and inform the patient regarding activity levels during the healing period. Patient compliance during the healing period is critical for a successful outcome.