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Advantage Ultra System and Advantage Fit Ultra System The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The Advantage Ultra System and the Advantage Fit Ultra System delivery devices are intended for use as an aid in insertion, placement, fixation, and anchoring of the Advantage Ultra surgical mesh during urogynecological procedures. Lynx Ultra System The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The Lynx Ultra System delivery device is intended for use as an aid in insertion, placement, fixation, and anchoring of the Lynx Ultra surgical mesh during urogynecological procedures.

Advantage Ultra System and Advantage Fit Ultra System The Advantage Ultra System and the Advantage Fit Ultra System are sterile, single-use systems each consisting of one delivery device and one blue mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device. The Advantage Ultra System and the Advantage Fit Ultra Systems are each packaged with their respective delivery device (Advantage Ultra or Advantage Fit Ultra delivery device). This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement. The Advantage Fit Ultra System includes the same mid-urethral mesh implant as the Advantage Ultra System but differs in the design of the dilators and delivery devices. The needle portion of the Advantage Fit Ultra delivery device has a smaller outer diameter and a smaller bend radius and is offered to provide physicians with surgical options. The Advantage Fit Ultra dilators also have a smaller diameter to accommodate for the different needle size. Lynx Ultra System The Lynx Ultra System is a sterile, single-use system consisting of two delivery devices and one blue mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of a delivery device.

The ArcSP Suprapubic Sling System is indicated to be placed mid-urethra for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The ArcSP Suprapubic Sling System consists of the following: - 1 ArcSP Sling with bio-resorbable Suture with plastic sheath - 2 ArcSP Handle and Needle Delivery Assemblies. The Handle and Needle delivery assembly is a sterile, single-use system, consisting of a two curved, stainless-steel Needles with attached Handles. The conical tip of each delivery Needle is designed to allow for passage through tissue. The Needles are a tool and together with the Sling Connectors and Sheaths, facilitate placement of the Sling and are not implanted. The ArcSP Sling assembly is identical to the predicate. ArcTV Sling assembly and includes one knitted polypropylene mesh with an integrated bioresorbable Suture, two removable plastic insertion Sheaths, and two Sling Connectors. The Suture is an integral feature of the Mesh. The integrated Suture helps to minimize deformation of the mesh during sling insertion and placement and allows for adjustment of the Sling after removal of the Sheaths. The two plastic Sheaths cover and facilitate placement of the Sling. The Mesh and the bioresorbable Suture are permanently implanted.

The polypropylene sling is indicated to be placed mid-urethra for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The ArcTO Transobturator Sling System consists of the following: - 1 ArcTO Sling with bio-resorbable Suture and plastic sheath . - 2 ArcTO Handle and Needle Delivery Assemblies . The Handle and Needle delivery assembly is a sterile, single-use system, consisting of two helical, stainless-steel Needles with attached Handles. The tip portion of each delivery Needle is designed to allow for passage through tissue. The Needles are a tool and together with the Sling Connectors and Sheaths, facilitate placement of the Sling and are not implanted. The ArcTO Sling assembly is identical to the predicate, ArcTV Sling assembly and includes one knitted polypropylene mesh with an integrated bioresorbable Suture, two removable plastic insertion Sheaths, and two Sling Connectors. The Suture is an integral feature of the Mesh. The integrated Suture helps to minimize deformation of the mesh during sling insertion and placement and allows for adjustment of the Sling after removal of the Sheaths. The two plastic Sheaths cover and facilitate placement of the Sling. The Mesh and the bioresorbable Suture are permanently implanted.

Desara TV EZ and Desara Blue TV EZ are intended to be used in females to position a mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The 3.0mm or 2.7mm surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara TV EZ and Desara Blue TV EZ surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The Desara TV EZ and Desara Blue TV EZ Systems are comprised of sterile, single-use midurethral slings used to provide support in the pelvic region to treat female stress urinary or mixed incontinence and a stainless steel disposable introducer in either a 3.0mm or 2.7mm diameter. The devices are intended to be used in females, via the transvaginal surgical approach in the in-patient or out-patient clinical setting. Desara TV EZ and Desara Blue TV EZ slings are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices include mesh placement aides consisting of: integral sleeves over the mesh, a removable EZ tab midline indicator and dilator tubes at each end of the device which attach to the 3.0mm or 2.7mm transvaqinal surqical introducer for placement of the mesh. All placement aids are removed after the device is positioned and only the mesh portion of the device remains as a permanent implant.

The mesh implant is intended for use as a suburethral sling for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Advantage Ultra System is a sterile, single-use system consisting of one delivery device and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device. The Advantage Ultra System is packaged with the Advantage™ System Delivery Device previously cleared via K172565. This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement. The Advantage Fit Ultra System is a sterile, single-use system consisting of one delivery device and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. The two dilators at the distal ends of the mesh assembly are designed to be placed over the needle end of the delivery device. The Advantage Fit Ultra System is packaged with the Advantage Fit™ System Delivery Device previously cleared via K172565. This is a single-use disposable delivery device that consists of a handle with a curved needle and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for retropubic placement. The Lynx Ultra System is a sterile, single-use system consisting of two delivery devices and one mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by two disposable polymer sleeves, two dilators, and one center tab. The sleeves and dilators are secured to the mesh by two polypropylene leader loops, and the center tab is secured to the mesh by a polyester lead. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of a delivery device. The Lynx Ultra System is packaged with two Lynx System Delivery Devices previously cleared via K172565. Each is a single-use disposable delivery device that consists of a handle with a curved needle with a needle slot for connection to the mesh assembly. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement.

The Athena Surgical RMUS System is indicated for use as a pubourethral sling for treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Athena Surgical RMUS System consists of a sterile, single-use Retropubic Mid-Urethral Sling (RMUS) Implant Assembly and a non-sterile, reusable RMUS Handle Assembly. Each RMUS Implant Assembly contains one blue polypropylene mesh sling implant (1.1cm x 46cm), covered by a non-implantable clear plastic sheath and attached on each end to nonimplantable stainless steel needles. The mesh implant is constructed of knitted filaments of extruded polypropylene strands and is approximately 0.63mm thick. The Athena Surgical RMUS Implant Assembly is designed to be used with the non-sterile, reusable Athena Surgical RMUS Handle Assembly, which consists of two parts: the Handle Body and the Handle Insert. The stainless steel needles from the RMUS Implant Assembly are designed to fit inside the RMUS Handle Assembly, which is used to position the implantable mesh in the patient from a vaginal incision up through the abdominal wall.

The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and are intended to facilitate in the placement of the GYNECARE TVT Device. The GYNECARE TVT Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically. The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT Device. The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and GYNECARE TVT Abdominal Guides and Couplers are included in each kit. The GYNECARE TVT Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT Device when placed in a top-down retropubic fashion (also known as an abdominal approach). The GYNECARE TVT EXACT Continence System is intended to be used as a pubo-urethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT EXACT Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically. The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT EXACT Continence System. The GYNECARE TVT Obturator Device is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT Obturator Device. The GYNECARE TVT ABBREVO Continence System is intended for use in women as a suburethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT ABBREVO Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO Device.

GYNECARE TVT™ Tension-free Vaginal Tape System: Consists of PROLENE™ Polypropylene Mesh (tape) with clear plastic Sheaths and stainless steel needles. The mesh is knitted filaments of extruded polypropylene strands. GYNECARE TVT™ Reusable Introducer (available separately) is a reusable stainless steel instrument. GYNECARE TVT™ Rigid Catheter Guide (available separately) is a non-sterile reusable stainless-steel instrument. GYNECARE TVT™ with Abdominal Guides Tension-free Support for Incontinence System: Includes GYNECARE TVT™ Abdominal Guide, a sterile disposable instrument, and GYNECARE TVT™ Coupler, a sterile disposable polypropylene connector. GYNECARE TVT EXACT™ Continence System: A sterile, single patient use procedure kit consisting of the GYNECARE TVT EXACT Continence System Trocar Sheath / Implant Assembly (blue PROLENE™ Polypropylene Mesh with clear plastic Sheaths and white Trocar Sheaths) and the GYNECARE TVT EXACT Continence System Trocar (stainless-steel Trocar Shaft and plastic Trocar Handle). GYNECARE TVT™ Obturator System: A sterile, single patient use procedure kit consisting of the GYNECARE TV Obturator Device (undyed or blue PROLENE™ polypropylene mesh with clear plastic sheath and plastic tube receptacles) and the GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide (two stainless steel, curved wire helical passers with plastic handles and a stainless steel accessory instrument). GYNECARE TVT ABBREVO™ Continence System: A sterile, single-patient use procedure kit consisting of the GYNECARE TVT ABBREVO Implant Assembly (blue PROLENE™ Polypropylene Mesh with clear plastic Sheaths and Helical Passer Sheaths, and Positioning Lines) and the GYNECARE TVT ABBREVO Placement Loop (PROLENE Polypropylene Monofilament loop with an attached polypropylene button). Also includes GYNECARE TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide (two stainless steel, curved wire helical passers with plastic handles and a stainless steel accessory instrument).

The ArcTV Transvaginal Sling System is a retropubic sling indicated for a transvaginal (TV) placement of a midurethral sling for the treatment of adult female stress urinary inconting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The ArcTV Transvaginal Sling System is a sterile, single-use system, consisting of a Handle, two delivery Needles and a Sling assembly. The tip portion of each delivery Needle is configured to allow for passage through tissue. The opposite end of the Needle is configured to connect with the Handle. The Handle is detachable and is used to direct both delivery Needles through tissue. The Sling assembly includes one piece of loosely knitted polymeric Mesh with an integrated bioresorbable Suture, two removable plastic insertion Sheaths, and two Sling Connectors. The Suture is an integral feature of the Mesh. The Suture and Mesh allow for adjustment of the Sling after initial placement in the patient without the use of additional tools. The two plastic Sheaths facilitate the placement of the Sling. The Sling Connectors, Sheaths, Needles, and Handle are used to facilitate placement of the Sling assembly, and are not implanted. The Mesh and the bioresorbable Suture are permanently implanted.

Desara® TV and Desara® Blue TV are intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

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Desara® Blue OV and Desara® Blue SS devices are intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Desara® Blue OV and Desara® Blue SS devices are sterile, single-use mid-urethral slings used to provide support in the pelvic region to treat stress urinary or mixed incontinence. The devices are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices have integral sleeves, tips and sutures to assist the surgeon in placement of the mesh, which are removed after placement of the device. Desara® Blue OV and Desara® Blue SS are designed to work with Caldera Medical's reusable introducers, which utilize a Universal Connection System offering surgeons the flexibility to choose their preferred surgical approach. Desara® Blue OV incorporates an overlapping sleeve design as an alternative to the centerline sleeve gap utilized in the predicate devices, Desara® and Desara® Blue, K132069. Desara® Blue SS incorporates a shorter suture length than that of the predicate devices. Desara® and Desara Blue, K132069.