InterGro® DBM

DBM in a Natural Carrier Designed to Provide Preferred Handling and Growth Factors

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Biocompatibility
The carrier used in InterGro DBM is composed primarily of phosphatidylcholine, commonly referred to as lecithin. Lecithin is 100% natural, derived from soybeans, absorbed by the human body, and is key component of cell membranes.

 

Preferred Handling
InterGro DBM is stored at room temperature and is available as a 40% DBM putty, 35% DBM paste, or a 35% DBM PLUS pre-mixed with Pro Osteon® 500R granules. Because InterGro DBM is non-water soluble, it resists lavage/irrigation.

 

Validated Osteoinductivity
Each lot of InterGro DBM is validated for osteoinductivity (OI) via the "C2C12" assay. This ensures that only lots with verified OI are released. The lecithin carrier helps to keep the DBM in situ as compared to DBM alone.1

 

Optimized Active DBM Content
To further enhance the osteoinductive response, the DBM content within the InterGro product has been optimized. The Nimni study2 showed a 60/40 ratio optimized ALP activity.

Indications

 

Product Description

InterGro® DBM products (InterGro DBM Putty, InterGro DBM Paste and InterGro DBM Plus) contain human tissue (allograft bone) and are intended for transplantation. The allograft bone has been granulated, demineralized and provided in a lipid carrier. The lipid carrier used in the manufacture of InterGro DBM products is extracted from soybean. The InterGro DBM Plus products contain porous ceramic granules that are a composite of highly resorbable calcium carbonate with a slower resorbing 2 μm to 10 μm outer layer of calcium phosphate.

 

Indications for Use

InterGro DBM products are to be used for filling bony voids or gaps in the extremities and pelvis that are not intrinsic to the bony stability of the structure, and as an autograft extender in the spine. InterGro Plus may also be used as a bone void filler in the spine (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. InterGro DBM may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm2. The amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site.

 

Contraindications

InterGro DBM products are contraindicated in patients with incomplete skull growth.

InterGro DBM products are contraindicated if active or latent infection is observed in or surrounding the implantation site.

 

Warnings and Precautions

InterGro DBM products are aseptically processed and remain aseptic during the stated shelf-life in an unopened and undamaged package. The product must be used before the expiration date. InterGro DBM must not be used under any of the following conditions:

  • If any of the package or product elements appear to be missing, tampered with or damaged; 
  • If the product label or identifying bar code is severely damaged, illegible, or missing;
  • If the expiration date shown on the package label has passed.

Do not subject InterGro DBM products or their packaging to disinfection or sterilization procedures. InterGro DBM is intended for single patient use only. To prevent cross-infection of graft recipients and graft contamination, do not use the contents on multiple patients. Empty or partially used containers should be disposed of in accordance with recognized procedures for discarding medical waste materials.

The production of all InterGro DBM products is performed in environmentally controlled conditions and under rigorous quality controls. The DBM component is processed with 50 units/mL Bacitracin, 500 units/mL Polymyxin B, Isopropyl Alcohol, Hydrochloric Acid, Sodium Phosphate Buffer, Hydrogen Peroxide and Allowash® solution, and may contain traces of these processing agents.

InterGro DBM products must be appropriately placed and/or fixed according to the clinical requirements for the specific procedure to avoid potentially adverse effects.

Closed suction or drainage is recommended to prevent wound fluid accumulation when using InterGro DBM products. Use of InterGro DBM may result in loss of contour.

Patient smoking may result in delayed healing, non-healing, and/or compromised stability in or around the placement site.

Product is for single use only. Re-use may result in product contamination, patient infection, and/or failure of the device to perform as intended.

 

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References

  1. Biomet Interpore Cross Test Report TR-0894 "Preliminary Evaluation of A DBM-Lecithin Composite.
  2. Han B, Tang B, and Nimni M. "Quantitative and Sensitive in vitro Assay for Osteoinductive Activity of Demineralized Bone Matrix" J Orthop Res. 2003 Jul;21(4):648-54.

Legal Manufacturer:

Zimmer Biomet Spine, Inc.
10225 Westmoor Dr.
Westminster, CO 80021 USA

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