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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)

ProGrip™ self-gripping polypropylene mesh is intended for use in reinforcement of abdominal wall soft tissue where weakness exists. The ProGrip™ self-gripping polypropylene mesh rectangular and square shapes are indicated for inguinal and ventral hernia repair.

Progrip™ self-gripping polypropylene mesh is designed to allow extraperitoneal mesh placement for the repair of inguinal and ventral hernias. Progrip™ self-gripping polypropylene mesh is made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side. Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes. The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors. Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial box or envelope with the eIFU leaflet and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial box or envelope (single pack configuration: 1 unit per commercial box or envelope).

Transorb™ Self-Gripping Resorbable Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in open procedures involving ventral hernia repair.

Transorb™ Self-Gripping Resorbable Mesh is designed for ventral hernia repair when placed in an extraperitoneal space by open surgical approach. Transorb™ Self-Gripping Resorbable Mesh is made of a fully resorbable bi-dimensional Poly-L-lactide, poly-trimethylene carbonate copolymer (PLLA/TMC) monofilament textile with monofilament PLLA/TMC absorbable grips on one side. Transorb™ Self-Gripping Resorbable Mesh is available in different shapes and sizes. Transorb™ Self-Gripping Resorbable Mesh is a macro-porous mesh knitted from resorbable monofilament PLLA/TMC yarns. It has been designed to reinforce soft tissues where weakness exists by providing strength and tissue integration throughout the expected healing period. Transorb™ Self-Gripping Resorbable Mesh has absorbable PLLA/TMC grips on one side that facilitate positioning and contribute to fixation. The PLLA/TMC mesh and grips degrade and resorb in vivo by hydrolysis in 36 to 60 months and are metabolized by the body into CO2 and H₂O.

Progrip™ Self-Gripping Polypropylene Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in procedures involving inguinal and ventral hernia repair by open approach.

Progrip™ self-gripping polypropylene mesh is a sterile non-pyrogenic device made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side. Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes. The non-absorbable textile is designed to ensure long term reinforcement of soft tissues. The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors. Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial envelope with the Instructions for Use (IFU) and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial envelope (single pack configuration: 1 unit per commercial envelope).

Parietene™ macroporous mesh is intended for the repair of hemias or other fascial deficiencies that require the addition of a reinforcing material.

The Parietene™ Macroporous Mesh is a non-absorbable synthetic surgical mesh made of bi-dimensional monofilament polypropylene textile. The Parietene™ Macroporous mesh is offered in a flat sheet and pre-cut mesh. The pre-cut mesh facilitates the repair of inguinal hernias via the anterior approach using a tension free technique. Parietene™ Macroporous Mesh is a single use device, presented sterile and unitary packaged in a single pouch and provided in a commercial box or sleeve with the labels and instructions for use. The device can be packaged in single pack (1 unit per sleeve) or multipack (3 or 6 units per box).

Symbotex™ Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries. ProGrip™ Self-Gripping Polyester Mesh is intended for use in reinforcement of abdominal wall soft tissues where a weakness exists in procedure involving inguinal and incisional hernias repair. Parietex™ Hydrophilic 2D 3D Anatomical Mesh is intended for reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving inguinal and incisional hernia repairs. Versatex™ Monofilament Mesh is intended for reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernia repairs.

The purpose of this Special 510(k) is to notify the Agency the changes made on Instructions for Use. There is no change performed on the devices itself, and the device description is identical to those provided for predicate devices Symbotex™ Composite Mesh (K142908), ProGrip™ Self-Gripping Polyester Mesh (K142900), Parietex™ Hydrophilic 2D 3D Anatomical Mesh (K173796) and Versatex™ Monofilament Mesh (K150091). Symbotex™ Composite Mesh is made out of a three-dimensional monofilament polyester textile which is covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol. The collagen film is essentially degraded in less than 1 month. For "Flat sheet" (SYM reorder codes): A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "Flat Sheet with sutures" (SYM-F reorder codes): Nonabsorbable pre-placed sutures are tied to the three-dimensional mesh. A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "With flap" (SYM-OS reorder codes): A dyed (D&C Green No. 6) bi-dimensional monofilament polvester textile flap is attached to the threedimensional reinforcement and helps place and fix the mesh. The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polyester and have polylactic acid monofilament resorbable pins on one of the sides. These pins facilitate placing, positioning and fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker on the medial edge of the pre-cut mesh helps orientation. The monofilament polylactic acid pins are bioresorbable and contribute to the fixation of the mesh to surrounding tissue during at least 8 weeks. The polylactic acid pins degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Two or three-dimensional multifilament polyester wall reinforcements. The two-dimensional mesh, with rectangular pores, is available in two different textures: a standard version (TEC references) and a rigid version (TECR references). The textures and transparencies of this mesh make them particularly suitable for the treatment of parietal affections, in particular inguinal hernias, through laparoscopic approach. The three-dimensional mesh (TET references) has hexagonal pores. The flexibility, porosity and low density of this mesh make it particularly suitable for the treatment of parietal affections, in particular incisional and inquinal hernias, through open approach. The Parietex™ hydrophilic 2-dimensional mesh, hydrophilic 3dimensional mesh and hydrophilic anatomical mesh has been adapted for various techniques of abdominal repair. The rectangular mesh is designed for the repair of inguinal and incisional hernias in a pre-peritoneal or pre-muscular approach. The pre-cut and slit mesh is suitable for the repair of inguinal hernias via anterior approach using the tension free technique. The folding mesh (in two-dimensional textile) is designed for the repair of direct or indirect inguinal hernias through a laparoscopic approach (trans-abdominal or pre-peritoneal or totally extra-peritoneal). Some codes have a slit for the passage of the cord. The anatomical mesh is mainly designed for the repair of inquinal hernias via laparoscopic or posterior open procedures and is available for the left and/or right side. Versatex™ Monofilament Mesh is made of macroporous three-dimensional monofilament polyester textile. Largest sizes include a green dyed monofilament polyester (D&C Green No. 6) marking that is positioned in the center of the textile to help center and orient the mesh.

Dextile™ Anatomical Mesh is intended to be used for the reinforcement of soft tissues where weakness exists during repair of inguinal hernia by laparoscopic approach.

Dextile™ Anatomical Mesh is designed to be placed in a pre-peritoneal site by laparoscopic approach. The device has an anatomical shape with sealed edges allowing coverage of inguinal hernia defects and facilitating laparoscopic mesh deployment and handling. The mesh is made of a non-absorbable macroporous monofilament polypropylene textile. A green marking is placed on the medial side of the mesh to help positioning and orienting the mesh: "ML" letters designate Medial Line. The green marking is made of monofilament polyester yarn. The "D&C Green No. 6" dye is used for the marking.

Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh is intended for the repair of inguinal and incisional hernias. Parietex™ Composite Mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The nonabsorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera. Parietex™ Optimized Composite Mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable threedimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh: The two-dimensional mesh, with rectangular pores, is available in two different textures: a standard version (TEC references) and a rigid version (TECR references). The three-dimensional mesh (TET references) has hexagonal pores. The Parietex™ hydrophilic 2-dimensional mesh, hydrophilic 3-dimensional mesh and hydrophilic anatomical mesh has been adapted for various techniques of abdominal repair. The rectangular mesh is designed for the repair of inguinal and incisional hernias in a preperitoneal or pre-muscular approach. The pre-cut and slit mesh is suitable for the repair of inguinal hernias via anterior approach using the tension free technique. The folding mesh (in two-dimensional textile) is designed for the repair of direct or indirect inguinal hernias through a laparoscopic approach (trans-abdominal or pre-peritoneal or totally extra-peritoneal). Some codes have a slit for the passage of the cord. The anatomical mesh is mainly designed for the repair of inguinal hernias via laparoscopic or posterior open procedures and is available for the left and/or right side. Parietex™ Composite Mesh is a composite mesh made out of a three-dimensional (3D) multifilament polyester textile for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin, polyethylene glycol and glycerol and juts out 5 mm over the edge of the reinforcement. For some references, a bi-dimensional (2D) multifilament polyester textile flap is attached to the 3D reinforcement and helps place and fixate the mesh (PCO-OS references). Parietex™ Optimized Composite Mesh is made out of a three-dimensional (3D) multifilament polyester for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol and juts out 5 mm over the edge of the reinforcement. The film is essentially degraded in less than 1 month. For some references, a bi-dimensional (2D) multifilament polyester textile flap is attached to the three-dimensional reinforcement and helps place and fixates the mesh (PCO-OSX references). For some references, one or many non-absorbable color monofilaments are tied (pre-placed sutures) to the three-dimensional mesh (PCO-FX references).

Duatene™ Bilayer Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. It is indicated for the open repair of groin hernia defects.

Duatene™ Bilayer Mesh is designed to be placed in an extraperitoneal site by open approach. Duatene™ Bilayer Mesh is a three-dimensional device made out of polypropylene monofilament textile knitted in one-piece. The three-dimensional textile is composed of: a posterior textile layer which is circular or elliptic in shape (for preperitoneal placement); an anterior textile layer which is oblong in shape (for onlay placement). The two textile layers are designed with differentiated knitting patterns, adapted to the function of each layer. The two layers are linked by crossing threads from both textiles. The mesh is designed to be placed over the groin region to ensure long term reinforcement of soft tissues.

Parietene™ DS Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. It is indicated for the repair of ventral hernias or other abdominal fascial deficiencies that require the addition of a reinforcing material.

Parietene™ DS Composite Mesh is designed to be placed in an intraperitoneal site by a laparoscopic or open approach. The mesh is composed of a permanent macroporous polypropylene textile on one side and a fully absorbable synthetic film on the other side. The film is adhered to the textile using a binding agent localized on the textile fibers. A violet marking is positioned on the mesh to help center and orient the mesh. Non-absorbable preplaced sutures are tied to the mesh. -The macroporous textile is knitted from a permanent monofilament polypropylene yarn. - The synthetic film is made out of absorbable synthetic copolymer of glycolide, caprolactone, trimethylene carbonate, and lactide. - The binding agent and the violet marking are made out of absorbable polycaprolactone. The D&C Violet No. 2 dye is used for the marking. - The pre-placed sutures are made out of an isotactic crystalline stereoisomer of polypropylene (a synthetic linear polyolefin) and polyethylene. The Copper Phthalocyanine Blue is used to color the sutures. The permanent macroporous textile is designed to be placed over the abdominal wall to ensure long term reinforcement of soft tissues, while the continuous absorbable film is designed to minimize tissue attachment to the mesh in case of direct contact with the viscera and is essentially degraded within 105 days by hydrolysis.