SurForce® Product Information

SurForce® Amniotic Tissue Allograft

SurForce®

SurForce® is a minimally manipulated, morselized flowable amniotic membrane tissue allograft designed to be the best product on the market today. It is an injectable allograft for homologous use only that allows the physician freedom to make precise applications.

SurForce® is thoroughly tested for safety in clinical procedures. Our donor serology test panel is the most extensive in the industry, testing for several potential pathogens that could be missed by less extensive testing observed in competitive industry products. SURGENEX® conducts a 14-day bacterial/fungal test performed by a third party lab, to confirm our products are free of bacterial and fungal contaminants. These safety barriers verify that SurForce® is the cleanest and safest amniotic membrane tissue allograft product on the market.

ITEM NUMBER

1050
1100
1200

AVAILABLE SIZES

1/2 CC
1 CC
2 CC

CONTRAINDICATIONS

SurForce® should not be injected into the spinal canal, in vital organs (including the heart and other areas of the central nervous system), nor the circulatory system. This product is not intended to be used as a bone substitute. SurForce® should not be injected in active infections nor patients that have conditions that would cause substantial risk of using this product. SurForce® has not been tested in combination with other products.

RECOMMENDED INSTRUCTIONS FOR SURFORCE®

The following are suggested recommendations as a guide and are not intended to supersede the professional and clinical judgment of the treating physician concerning patient care.

PREPARATION INSTRUCTIONS

Open the sterile pouch containing the vial and transfer onto a sterile working area. Allow to thaw completely (approximately 30 minutes). Once completely thawed, aspirate SurForce® using a 16g or 18g needle and syringe. Inject the allograft in the patient using a 22g needle or larger size needle.

CONTENTS AND DESCRIPTION

SurForce® is a cryopreserved flowable allograft tissue matrix available in a variety of vial sizes. Each vial is visually inspected and carefully tested for quality assurance before delivery. If you received an open or broken vial, do not use it. Immediately contact SURGENEX®, LLC customer service. SurForce® is intended to be used on a single patient, as a one-time use only. Once SurForce® is properly thawed, it must be used immediately or promptly discarded.

SurForce® has been tested for relevant communicable diseases in accordance with the required FDA standards for tissue donation. SURGENEX®, LLC may test beyond this FDA minimum for additional pathogens at its discretion in order to ensure patient safety. Additionally, before delivery, the product is tested twice using a bacterial and fungal culture as an added precaution.

NOTICE

Federal law requires HCT/P to be sold by or on the order of a licensed physician. Any violation will be subject to Federal law. The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent

Following use, dispose of any unused product and packaging following current accepted medical practices and follow all relevant local, state and federal laws and regulations.

DONOR ELIGIBILITY REQUIREMENTS

An allograft of donated human tissue is deemed qualified for transplantation by an authorized recovery agency by meeting the following criteria:

Results from the donor pre-screening lab tests specify the donor to be free from risk factors and active infections of applicable communicable disease agents and diseases as required by the FDA.

Donor results from the pre-screening lab tests must be negative and/or non-reactive for the following applicable communicable disease agents.

Prescreening

HIV I/II AB
HIV/HCV/HBV NAT
HBC AB
HBS AG
RPR
HCV AB
HTLV I/II

DONOR SELECTION PROCESS

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, all contracted laboratories performing human specimen tests are certified and meet the requirements as determined by the Centers for Medicare and Medicaid Services (CMS).

All donor recoveries meet and adhere to the regulations requisite to HCT/P recovery and the screening and testing of the tissue donor as verified through the tests noted in the section of pre-screening lab tests above.

Utilizing the U.S. Public Health Service guidelines, the donor’s relevant medical history and behavioral risk assessments are obtained preceding donation.

The qualified recovery agency evaluates the results of the blood sample tests, the relevant medical history, and the examinations pertaining to donor tissue eligibility. Discussions with either physicians or the donor mother are performed to identify situations that may disqualify the donor.

These results conclude that the donor suitability criteria meet the standard requirements for transplantation. Specific and detailed information of the testing laboratories, required infectious disease tests results, listings of documents reviewed as part of the pertinent medical records, and all necessary donor medical information of any specific allograft tissue recovered via SURGENEX®, LLC is stored in our facilities and/or affiliated facilities.

STORAGE REQUIREMENTS

It is the responsibility of the clinician to store SurForce® in its original packaging until ready for use. SurForce® can be maintained at -18°C or colder for three months or until expiration date printed on product packaging, whichever comes first. Recommended long-term storage is at – 80°C using an ultra-low temperature freezer or liquid nitrogen until the expiration date printed on the sterile pouch is reached.

Following use, dispose of any unused product and packaging following current accepted medical practices and follow all relevant local, state and federal laws and regulations.

HCT/P TRACKING

The Joint Commission and FDA requires patient records to be properly maintained by storing the allograft ID number (LOT NUMBER) for purposes of tracking the allograft post treatment. Please go to our website www.surgenex.com/records and register by using the lot number provided on the silver pouch.

RETURN POLICY

SURGENEX®, LLC accepts no returns of SurForce®. Although SURGENEX®, LLC has taken great measures to ensure the safety of our allograft product, current technologies cannot preclude the transmission of certain diseases known or unknown, therefore, SURGENEX®, LLC can make no claims concerning the biological properties and safety of allograft tissue. All tissues have been collected, processed, screened, tested, stored, and distributed in compliance with all current FDA regulations concerning HCT/Ps.

Application and use of any allograft tissue may potentially have negative outcomes. Occurrence of complications at the affected site may transpire post-treatment without early warning signs. These include, but are not limited to 1) transmission of communicable diseases, 2) transmission of infectious disease agents such as: bacteria and fungus, viruses; and 3) immune rejection of, and/or allergic reaction to, injected HCT/P.

PRECAUTIONS

Caution should be taken when administering this product to immunocompromised individuals, such as patients suffering from HIV or other highly immunocompromised conditions.

DMSO is used as a cryoprotectant. Therefore, SurForce® should not be used by patients with known sensitivities or allergies to DMSO.

SURGENEX®, LLC and its affiliates furnish this allograft product without any express or implied warranties. All statements or descriptions are informational only and are not to be interpreted or implied as a warranty of the allograft product. SURGENEX®, LLC and its affiliates make no guarantee regarding the biological characteristics of this product. The end user shall be held responsible for determining the appropriate application and usage of this product.

Top questions from providers

Answer

We hold ourselves to a higher standard to perform above and beyond the minimum requirements in the industry, ensuring best practices and superior product outcomes. SurForce has been tested for relevant communicable diseases in accordance with the required FDA standards for tissue donation. Additionally, our donor serology test panel is the most extensive in the industry, testing for several potential pathogens that could be missed by less extensive testing observed in competitive industry products. SURGENEX® conducts a 14-day bacterial/fungal test performed by a third-party lab, to confirm our products are free of bacterial and fungal contaminants. These two safety barriers verify that SurForce® is the cleanest and safest amniotic membrane tissue allograft product on the market.

Answer

SurForce® is an amniotic membrane injectable categorized as Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/P’s) under Section 361. Currently, the FDA regulates all biological regenerative products under this Section. Moreover, under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR part 493, all contracted laboratories performing human specimen tests are certified and meet the requirements as determined by the Centers for Medicare and Medicaid Services (CMS). SURGENEX® is current in the FDA Establishment Registration and Listing of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/P).

Answer

Donor eligibility requirements are set forth and regulated by the FDA to ensure the Donor of the Placental tissue for transplantation is free of specific infectious and communicable diseases. Donor recoveries meet and adhere to the regulations requisite to HCT/P recovery. Screening and testing of the tissue donor is verified through laboratory serology test panels. Once all criteria are satisfied, the donor placental tissue is deemed qualified for processing and transplantation

Answer

The FDA requires HCT/P products under section 361 to be traceable in the event of an adverse reaction. Lot tracking is utilized as a course of action for documenting the management and storage of a specimen from donor to collector to the final transplant destination, and the review and reporting of the final results by a Healthcare Provider.

Answer

SURGENEX®, LLC accepts no returns of SurForce®. Although SURGENEX®, LLC has taken great measures to ensure the safety of our allograft product, current technologies cannot preclude the transmission of certain diseases known or unknown, therefore, SURGENEX®, LLC can make no claims concerning the biological properties and safety of allograft tissue. All tissues have been collected, processed, screened, tested, stored, and distributed in compliance with all current FDA regulations concerning HCT/Ps.

Answer

SurForce® is an Amniotic membrane allograft cryopreserved, with highest concentration of amniotic membrane compared to any other products derived from placental tissue. Research shows amniotic membrane contains growth factor components, anti-fibrous functions, anti-microbial properties, immune-evasive properties, pain management and anti-inflammatory properties, as well as the potential to repair articular cartilage. Please peruse our Research section here for research articles related to the incredible benefits of amniotic membrane allograft tissue.

Answer

Autograft is defined as a graft of tissue from one point to another of the same individual's body, simply, a host to host implantation of tissue. Whereas an Allograft is a tissue graft from a donor of the same species as the recipient but not genetically identical, or simply, a Donor to Host Transplantation of tissue.

Answer

We are not entirely sure as to why Autograft companies describe our product as Amniotic fluid, however, the claim is quite misleading and a false equivalent as our product is derived from the amniotic membrane.

Answer

Distribution of SURGENEX® products are cryopreserved and shipped in shipping containers utilizing dry ice to maintain critical low temperatures.

Answer

Our shipping solutions are designed to maintain its ultra-cold temperature integrity for up to 72 hours. Overnight shipping is the standard service that SURGENEX® provides its customer base, however, there are rare occasions in which packages encounter delays in the distribution chain due to inclement weather or mechanical failures of Courier equipment.

Contact Us

SURGENEX® LLC
PO Box 4664
Scottsdale, AZ 85261
Corporate: 877.880.1862
Sales: 877.880.1862 ext 1

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