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The SIS Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists. Indications for use include repair of a hernia or body wall defect. The graft is supplied sterile and intended for one time only use.

The SIS Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at time of implant. The SIS Hernia Graft is identical in its base material to its predicate SIS Hernia Repair Device (K974540/K062697), also manufactured by Cook Biotech Incorporated. The SIS Hernia Graft is substantially equivalent to its predicate in its technology in that it has the ability to be incorporated into the body. The device is substantially equivalent to its predicate in its intended use for reinforcement and repair of hernias or a body wall defect. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.

The Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists, including the repair of diaphragmatic/hiatal hernias. The graft is supplied sterile and intended for one time use.

The Diaphragmatic Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at the time of implant. The Diaphragmatic Hernia Graft is identical in its base material to its predicates SIS Hernia Repair Device (K974540/K062697) and Surgisis Staple Line Reinforcement (K022044), also manufactured by Cook Biotech Incorporated, and similar to its predicate Permacol™ Surgical Implant (K120605), manufactured by Covidien. The Diaphragmatic Hernia Graft is substantially equivalent to its SIS predicates in that its technology is able to be incorporated into the body. The device is also substantially equivalent to its predicates in its intended use for reinforcement and repair of diaphragmatic/hiatal hernias. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.

The Biodesign Onlay Dural Graft is intended for use as a dura substitute for the repair of dura mater. The device is provided sterile and intended for one-time use.

The Biodesign Onlay Dural Graft is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material that comprises the Biodesign Onlay Dural Graft is identical in composition and technology to that of its predicate Durasis Dural Substitute (K031850), also manufactured by Cook Biotech Incorporated and similar to its other predicate, DuraGen II Dural Regeneration Matrix (K043427) manufactured by Integra LifeSciences. The Biodesign Onlay Dural Graft is implanted as a dura substitute providing a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. The device is packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system. The Biodesign Onlay Dural Graft can be placed without sutures during skull base dural repair.

The Hybrid Graft is for implantation to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The graft is supplied sterile and is intended for one-time use.

The Hybrid Graft is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS) and a polypropylene mesh. The collagen matrix is identical to the predicate SIS Hernia Repair Device (K974540, K062697), manufactured by Cook Biotech Incorporated. The polypropylene mesh is similar to the predicates PROCEED™ Ventral Patch (K061533) and ULTRAPRO® Mesh (K033337), both manufactured by Ethicon, Incorporated. The Hybrid Graft is similar to both PROCEED and ULTRAPRO in that all are made of a composite of a bioabsorbable or collagen-based and synthetic (polypropylene) component. The polypropylene mesh in the Hybrid Graft is layered between six (6) layers of SIS on the side facing the viscera and two (2) layers of SIS on the side facing the body wall. The device is packaged in a vacuum pressed (dried), laminated state and supplied sterile in a sealed double pouch system.

The Biodesign Nipple Reconstruction Cylinder is intended for implantation to reinforce soft tissue where weakness exists, in plastic and reconstructive surgery of the nipple. The cylinder is supplied sterile and is intended for one-time use.

The Biodesign Nipple Reconstruction Cylinder is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material is identical to the predicates SurgiSIS® Mesh (K980431, K062696), SIS Plastic Surgery Matrix (K034039), and SIS Facial Implant (K050246, K070738) all manufactured by Cook Biotech Incorporated. The Biodesign Nipple Reconstruction Cylinder is a rolled SIS mesh and available in sizes from 0.7 cm in diameter and 1.0 cm to 2.5 cm in length. The cylinder is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The device is implanted using a skin flap procedure that prevents migration of the device. A PET marking template (Class I, 21 CFR 888.4800) and silicone (35A durometer) nipple shield (Class I, 21 CFR 880.5630 ) to be placed over the cylinder post-operatively, are included with the device. The use of the Biodesign Nipple Recosntruction Cylinder, an off-the-shelf graft, is advantageous in that a donor site is no longer necessary.

The COOK® Urological Graft is for implantation to reinforce soft tissues where weakness exists in the urological anatomy, including temporary wound or solid organ support in the kidney. The Urological Graft is supplied sterile and intended for one-time use.

The COOK® Urological Graft is a bioabsorbable, extracellular collagen matrix that is identical to the predicates SURGIS Mesh (K980431) and SURGISIS® Sling (K992159), also manufactured by COOK Biotech Incorporated, and to Vicryl Mesh bag (K051701), manufactured by Ethicon. The device is manufactured from porcine small intestinal submucosa (SIS), packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.

The modified SIS Fistula Plug is indicated for implantation to reinforce soft tissue for repair of enterocutaneous fistulas.

The modified SIS Fistula Plug is manufactured from porcine small intestinal submucosa (SIS) supplied in a tapered configuration with a flange to provide increased retention of the plug and improved blockage of the fistula. The device is packaged in a lyophilized (freeze-dried) state, and supplied sterile in a sealed double pouch system.

DynaMatrix™ is intended for use to aid in guided tissue regeneration and guided bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or enhance alveolar ridges, or to contain and prevent migration of graft material. The device is provided sterile and intended for one-time use.

DynaMatrix™ is a bioabsorbable, extracellular collagen membrane matrix that is identical to the predicate SURGISIS® Periodontal Membrane (K010952), also manufactured by Cook Biotech Incorporated. This premarket notification is being submitted to expand the indications for use and to introduce a new product name.

The SURGISIS® Biodesign Tissue Graft is intended to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect. The SURGISIS® Biodesign Tissue Graft minimizes tissue attachment to the device in case of direct contact with viscera. This device is intended for one-time use.

The SURGISIS® Biodesign Tissue Graft is manufactured from porcine small intestinal submucosa (SIS) and is nominally supplied in a range of sizes. The device is packaged in a dried state, and is supplied sterile in a sealed double pouch system.

The SURGISIS® SLR™ Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding, and for reinforcement of staple lines during small bowel, mesentery, colon, and colorectal procedures. The device may be used with anastomotic staplers or with non-anastomotic staplers. The device is supplied sterile and is intended for one-time use.

The SURGIS & SLR™ Staple Line Reinforcement device is produced from porcine small intestinal submucosa (SIS") that has been disinfected and treated for surgical use. The modified device is coated with an adhesive that eliminates the need for the application of a hydrogel to affix the device to the stapler arms. The device is supplied on a foam applicator, suspended in a form-fitting tray, and packaged in a sealed foil pouch to maintain sterility.