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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.

Restrata® MiniMatrix is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores / ulcers, venous ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wounds (e.g., donor site / grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced wounds), trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), and draining wounds.

Restrata MiniMatrix is a sterile, single use device intended for the local management of wounds. Restrata MiniMatrix is a form of Restrata Matrix that can be dispersed at the wound site during application. The device is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity similar to native extracellular matrix. Restrata MiniMatrix completely degrades via hydrolysis. The device does not contain any human or animal materials or tissues. Restrata MiniMatrix is supplied in a nested pouch configuration, placed within a shelf-box. The product is terminally sterilized. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.

Restrata® is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores/ ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-Mohs surgery, podiatric wounds, dehisced wounds), trauma wounds (e.g., abrasions, partial thickness burns, skin tears), and draining wounds.

Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix. Restrata® is a porous matrix with a defined rate of resorption that provides a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. The device permits the ingress of cells and soft tissue formation in the defect space / wound bed. The device does not contain any human or animal materials or tissues. Restrata® is terminally sterilized, in a single use double peel package in a variety of sizes in non-meshed and meshed configurations. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged. The subject device is a modification of the predicate device to include updated product labeling, a change in product size offerings, and a change in product design offerings.

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.

Restrata™ Wound Matrix is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores/ ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-Mohs surgery, podiatric wounds, wound dehiscence), trauma wounds (e.g., abrasions, partial thickness burns, skin tears), and draining wounds.

The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body's natural healing process to occur. Restrata™ is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix. Restrata™ is a porous matrix with a defined rate of resorption that provides a scaffold for cellular infiltration and vascularization before completely degrading via hydrolysis. The device permits the ingress of cells and soft tissue formation in the defect space / wound bed. The device does not contain any human or animal materials or tissues. Restrata™ Wound Matrix is supplied terminally sterile, in a single use double peel package in a variety of sizes. Contents of the package are guaranteed sterile and non-pyrogenic unless the package has been opened or damaged.

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.

The Cerafix® Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 1.9 in² (12.5cm²) or less in area. For example, 1.2 in x 1.6 in (3 cm x 4 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.