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For implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.

Restrata Soft Tissue Reinforcement (STR) is an electrospun fiber matrix intended for implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery. Restrata Soft Tissue Reinforcement is composed of resorbable synthetic fibers engineered from biocompatible materials. The fibers comprising Restrata STR are produced from polyglactin 910 (PGLA 90:10) and polydiaxonone (PDO). Contents of the package are provided sterile. The device is intended for one-time use.

Helios Dura Regeneration Matrix is indicated as a dura substitute for the repair of the dura mater.

Helios Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. The single-use device is supplied sterile in sheet form in a variety of sizes ranging from 6.5 - 250 cm² (~1 - 40-in²) to be trimmed and sutured or onlayed by the surgeon to meet the individual patient's needs.

ArtiFascia is indicated as dura substitute for the repair of dura mater. ArtiFascia is indicated for defects of 25cm² (3.87 in²) or less in area. For example, 6 cm X 4 cm (24 cm²) would be an acceptable defect size.

ArtiFascia is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFascia is a highly flexible, easy to handle, non-friable soft matrix composed of synthetic non-woven fibers and a non-porous film. ArtiFascia is packaged in a single-use peelable package and is provided sterile, nonpyrogenic. ArtiFascia readily conforms to the surface of the wound area and is applied to the dural defect by using sutures.

SYNTHECEL® Dura Repair is indicated as a dura replacement for the repair of dura mater in adults.

SYNTHECEL® Dura Repair is composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SYNTHECEL® Dura Repair functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SYNTHECEL® Dura Repair is immunologically inert and has demonstrated minimal foreign body response. It is non-resorbable.

The DuraSure Biologic Patch is intended for use as a surgical patch material to close dura mater during neurosurgery.

The DuraSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. The DuraSure is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution. The DuraSure is designed to repair the body's natural organs.

The Cerafix Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.9 in2 (31.7cm2) or less in area. For example, 4.0 in x 1.2 in (10.0 cm x 3.1 cm) would be an acceptable defect size.

Cerafix® Dura Substitute is a resorbable implant for repair of dural defects. The device can be applied as an onlay matrix or sutured in place. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. Cerafix® Dura Substitute is available in a variety of sizes and is supplied sterile and nonpyrogenic in a single-use nested pouch configuration, which is enclosed within a protective chipboard envelope.

DuraGen® Secure Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.

DuraGen® Secure Dural Regeneration Matrix is an absorbable implant for the repair of dura mater. This absorbable, sutureless onlay graft is comprised of a porous, highly purified collagen matrix and a thin layer of hydroxypropyl methyl cellulose (HPMC). HPMC is a non-cytotoxic, non-immunogenic, biocompatible plant-derived cellulose-based material. The addition of HPMC results in a dural graft which reduces the potential for the product to migrate, slide or displace during the surgical procedure, such as during irrigation of the surgical site or in a standing pool of fluid, without the use of sutures.

Durepair is indicated as a dura substitute for the repair of the dura mater.

Durepair® Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. Durepair is supplied sterile, in a double-peel package, and is intended for single (one-time) use-only. Durepair is available in a variety of sizes intended to be cut by the surgeon to the desired shape.

The Cerafix® Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 4.4 in2 (28.3 cm2) or less in area. For example, 4.0 in x 1.1 in (10.1 cm x 2.8 cm) would be an acceptable defect size.

Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. Cerafix® Dura Substitute is available in a variety of sizes and is supplied sterile and nonpyrogenic in a single-use nested pouch configuration, which is enclosed within a protective chipboard envelope.

Biodesign Tissue Graft is intended to be used for implantation to reinforce soft tissue Biodesign Dural Graft is intended for use as a dura substitute for the repair of dura mater. Biodesign Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie's disease.

The three subject devices of this bundled submission share many of the same technological characteristics: - Composed of multilayered sheets of processed porcine small intestinal submucosa (SIS). - Packaged in a Tyvek/PE double pouch. - Shelf-life of 18 months - Sterilized using ethylene oxide. The only differences between the three devices are the indications (and associated labeling) and the dimensional specifications (analogous to the indication and anatomic requirement for each device). Both the indications and the dimensional specifications of each subject device, however, are unchanged from the corresponding predicate device.