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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.

Bard® Mesh is indicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects. Bard® Mesh Pre-shaped is indicated for the repair of inguinal hernia defects.

The Bard® Mesh is a nonabsorbable, sterile mesh designed for the reinforcement of soft tissue where weakness exists, i.e., repair of hernias and chest wall defects. The Bard® Mesh Pre-Shaped is a nonabsorbable, pre-trimmed sterile mesh designed for reinforcement of inguinal hernias. The Bard® Mesh is offered in several sizes of rectangular flat sheets and in several pre-shaped configurations, known as Bard® Mesh Pre-Shaped. Bard® Mesh product family products consist of the standard, rectangular or square sizes which can be trimmed as needed to provide surgeons with more freedom to customize the prosthesis prior to implantation. The Bard® Mesh portfolio currently ranges from 1" x 4" to 10" x 14" rectangle mesh. The Bard® Mesh is comprised of knitted polypropylene monofilaments in a square or rectangular flat sheet with selvage edges. The Bard Mesh Pre-Shaped is comprised of knitted polypropylene monofilaments in a pre-shaped configuration with a pre-cut into a shape commonly used by surgeons to protect the spermatic cord or similar structure as part of an inguinal hernia repair. All clinical, biological, and technical characteristics of the Bard® Mesh and Bard® Mesh Pre-Shaped are identical except that Bard® Mesh Pre-Shaped is only indicated for inguinal hernias due to the pre-cut/pre-shaped nature of the product.

TYBR Collagen Gel is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.

TYBR Collagen Gel is a naturally-derived collagenous semi-permeable barrier device that conforms to the application site and degrades within 30 days. The TYBR Collagen Gel includes a blue color additive to aid with visualization. The applicator provides controlled delivery of the collagen gel to support uniform coverage at the desired location.

Kerecis® Tendon Protect is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Kerecis® Tendon Protect is a medical device made from solid fish skin (North Atlantic Cod) sheets of thickness no less than 0.4 mm. The product is intended to provide a covering around the newly repaired tendon for the management and protection of tendon injuries in which there has been no substantial loss of tissue. The device with natural structure and proteins from fish skin is applied around the newly repaired tendon. The structure of the fish skin provides a supportive environment for new host tissue deposition as part of wound healing while still providing an initial barrier facilitating the sliding of the repaired tendon within the surrounding tissue during tendon use. The biomechanical strength for the tendon itself is provided separately by sutures used to repair the tendon tear and/or by sutures or bone anchors used to attach the tendon tissue to the bone. The fish skin is fully integrated into the surrounding tissue over time, with corresponding new host tissue deposition. The device is biocompatible, non-crosslinked, bioresorbable, strong, and pliable. Its tensile strength supports fixation by sutures customary for tendon protection surgical procedures. The device is intended for one-time use and supplied sterile in labelled Tyvek® pouch packaging. The subject device is available in following sizes: - 3x5 cm size - 6x9 cm size Kerecis® Tendon Protect is a standalone, single use medical device made from fish skin that is technologically similar to the predicate device Tendon Wrap Tendon Protector (K053655) (Substantial Equivalence) and identical to the Kerecis® Reconstruct™ (K202430).

Endoform™ Reconstructive Template – PLGA is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing material to obtain the desired surgical outcome.

Endoform™ Reconstructive Template – PLGA is a surgical mesh comprised of multiple layers of ovine-derived extracellular matrix reinforced with poly(lactic-co-Glycolic) acid (PLGA). The device design includes a range of shapes, sizes, and thicknesses in surface areas up to 400cm², to give a range of strengths as required for a particular implant procedure. Devices are terminally sterilized by ethylene oxide (EO) sterilization.

The TeKBrace Solo Soft Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. The TeKBrace Solo Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

The TheraMicro TekBrace Solo Soft Tissue Reinforcement Device is a single use device intended to be used for reinforcement of soft tissue. The product is offered in a central tubular weave tape that tapers down to cords at both ends. The implant is available in two sizes. The device will have pockets which provide access to the inside of the tubular section. The product is substantially equivalent in material and manufacturing compared to the Xiros Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (K222978 and K220091). TekBrace Solo is similar to the Xiros Infinity-Lock predicate in intended use, material and design, including a central tubular section tapering down to cords at the end. TekBrace Solo is manufactured from non-absorbable polyethylene terephthalate (PET), commercially known as polyester. The implant is manufactured from fibers of long-chain, linear polyester having recurrent aromatic rings. The device also incorporates Cottony II green PET suture for pocket location visibility.

The SuturePatch Tissue Reinforcement is intended for the management and protection of soft tissue injuries. The SuturePatch Tissue Reinforcement is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures, or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. The SuturePatch Tissue Reinforcement device reinforces and protects healing soft tissues. The SuturePatch Tissue Reinforcement device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the repair.

The Arthrex SuturePatch Tissue Reinforcement device is a non-absorbable, permanent, implantable orthopedic surgical mesh intended for the reinforcement of soft tissue/tendon repair. It is manufactured from embroidered polyester yarns with integral reinforcements across its width and around its perimeter to provide improved stability and high suture retention strength. The SuturePatch is available in rectangular and trapezoidal patterns and configurable sizes. Sutures passed through soft tissue can also be passed throughout the SuturePatch with needles or suture passer.

3DMatrix DynaFlex (DynaFlex) is indicated for the reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. Examples of applications where DynaFlex may be used include: - Suture line reinforcement including for hernia repair - Muscle flap reinforcement - General tissue reconstructions

3DMatrix DynaFlex ("DynaFlex") is a single-use, fully absorbable, colorless, non-woven, 3D-printed, macroporous, polymeric surgical mesh made entirely of uncolored and undyed polydioxanone (PDO). DynaFlex is provided in three sizes, 6 cm x 5.5 cm, 6 cm x 14.5 cm, and 5 cm x 17 cm, that can be cut to the desired shape and size for each specific application at the time of use. DynaFlex is terminally sterilized by Ethylene Oxide validated to an SAL of 10-6 and intended to be used by prescription only in a healthcare facility or hospital. Once implanted, DynaFlex acts as a mechanical support to soft tissues and provides a scaffold for tissue ingrowth. It is designed to fully degrade over six to seven months. DynaFlex provides temporary mechanical support and stabilization during the healing process. DynaFlex mesh is not isotropic so the mechanical properties of DynaFlex mesh are direction dependent.

Parietene™ macroporous mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair.

Parietene™ macroporous mesh is designed for extraperitoneal mesh placement only, for the repair of abdominal wall hernias by laparoscopic or open approach. Parietene™ macroporous mesh is a non-absorbable synthetic surgical mesh made of two-dimensional (2D) monofilament polypropylene knitted textile. Parietene™ macroporous mesh is offered in square flat sheet version (50cm x 50cm). The non-absorbable textile is designed to ensure long term reinforcement of soft tissues. The macroporous textile provides strength required to withstand biomechanical stresses throughout the healing period, while allowing for tissue ingrowth. As the textile integrates, host tissue ingrowth is intended to provide strength to the repair. The detailed composition listed below refers to the estimated maximum amount of each material and substance to which a patient can be exposed when 1 unit of the largest size of Parietene™ macroporous mesh is implanted (i.e. PPM5050). This amount could be less if the mesh is trimmed by the practitioner prior to implantation. Mesh composition: monofilament polypropylene yarn (up to 11.5 g)