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The Repose™ Bone Screw System is intended for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw with pre-threaded suture. It is also suitable for the performance of a hyoid procedure. It is indicated for the treatment of obstructive sleep apnea ("OSA") and/or snoring.

The Repose™ Bone Screw System consists of three main components: a bone screw attached to surgical suture material, a bone screw inserter, and a suture passer. The Repose™ Bone Screw is a sharp tipped, small diameter titanium screw with polypropylene monofilament no. I suture crimped into its base. The Repose™ Bone Screw Inserter is a disposable, battery operated, single use device. The Repose™ Suture Passer is designed to assist in passing the suture through the floor of the tongue in a tongue base advancement procedure or through the neck during a hyoid suspension procedure.

The Cryo-Mono Cryogenic System is intended for cryogenic destruction of tissues during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, and prostate tissues. Cryo-Mono with TUF probe is specifically indicated for the ablation of prostate tissue in cases of benign prostatic hyperplasia ("BPH").

The Cryo-Mono is a modified version of Cryo-Hit. They have the same technological characteristics with several exceptions: The primary technological differences between the Cryo-Mono with TUF probe and the Cryo-Hit are: (1) Cryo-Mono with TUF accepts only one cryoprobe, the TUF probe, which is one of the options for the Cryo-Hit; (2) The Cryo-Mono with TUF probe is smaller than Cryo-Hit; (3) The Cryo-Mono with TUF probe has fewer gas cylinders; (4) The physician manually applies the Cryo-Mono's probe while with the Cryo-Hit, the physician has the option to use the "Stick" mode, which automatically adheres the probe to the tissue; (5) The Cryo-Mono with TUF probe has an optional foot pedal control; (6) The Cryo-Mono with TUF probe delivers preset amounts of argon for cooling while the Cryo-Hit adjusts the amount of argon delivered based on the tissue temperature measured by its thermocouples; (7) The Cryo-Mono with TUF probe's iceball size is monitored by transrectal ultrasound; the use of ultrasound, as well as external theromcouples, is optional with the Cryo-Hit; and (8) The Cryo-Mono's TUF probe is delivered transurethrally through a cystoscope rather than transperineally as with the Cryo-Hit. The only modification to the device' s software was the removal of the "stick" option mentioned above. The Cryo-Mono's single-use probes are within the range of probes that can be used with the Cryo-Hit, i.e. one to eight probes.

The StapleTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors. It is indicated for vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The StapleTac Bone Anchor System is substantially equivalent to Influence, Inc.'s MicroTac Bone Anchor System cleared under K990160 with respect to intended use, materials and performance of the bone anchors. The major difference between the two systems is that the anchor of the StapleTac Bone Anchor System is designed for sling fixation with a staple and without sutures in sling procedures only, while the predicate device is designed for use with sutures in both sling procedures and cystourethropexy.

The Cryo-Mono Cryogenic system is intended for cryogenic destruction of tissues during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctocology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, tonsils, turbinate reduction and prostate tissues. Cryo-Mono is specifically indicated for tonsil reduction in patients with blood dyscrasias or other bleeding problems and/or patients for whom general anesthesia presents an increased risk.

The Cryo-Mono is a modified version of Cryo-Hit. They have the same technological characteristics with several exceptions: (1) Cryo-Mono can support one cryoprobe only, while its predicate, Cryo-Hit, is capable of supporting up to 8 probes; (2) the Cryo-Mono is smaller than Cryo-Hit. (3) the Cryo-Mono has 4 gas cylinders compared to the Cryo-Hit' s six; (4) Cryo-Mono software has been modified, and does not have a "Stick" option for holding the probe to the tissue during freezing; (5) Cryo-Mono can accommodate needle shaped, tonsillectomy and turbinectomy specific probes; (6) Cryo-Mono has an optional foot pedal; (7) The Cryo-Mono does not have external thermosensors, which the Cryo-Hit has; and (8) The Cryo-Mono's single-use turbinectomy and tonsillectomy cryoprobes do not have built-in thermosensors, unlike the Cryo-Hit and Cryo-Mono' s multi-use probes.

The MicroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with sutures. It is indicated for cystourethropexy and vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The MicroTac Bone Anchor System, consisting of the MicroTac Bone Anchor and the MicroTac Bone Anchor Inserter. The inserter of the MicroTac Bone Anchor System is designed for single use and is manual.

The Straight-In - Orthopedic Bone Screw Fixation System is intended for soft tissue fixation to bones by means of bone screws threaded with sutures. It is indicated for use during surgical procedures where soft tissue fixation to bones is needed, such as: 1. Repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromiociavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction. 2. Repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation. 3. Repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament. 4. Repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis. 5. Repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.

The Orthopedic Straight-In Bone Screw Fixation System is intended for soft tissue fixation to bones by means of bone screws threaded with sutures. The design and materials of the Orthopedic Straight-In and Short shaft Straight-In systems are identical. The differences are that the Inserter of the Orthopedic Straight-In is designed for use in 10 procedures, while the predicate device is designed for single use.

The In-Probe II Urodynamic System is indicated as an aid in the diagnosis of voiding dysfunction in males and females. In females, the In-Probe II Urodynamic System is also indicated for measuring urethral angle during straining.

The In-Probe II Urodynamic System is a compact and portable urodynamic system capable of performing cystometrography (CMG) for both men and women. In addition, for women, the device can provide objective measurement of the changes in urethral angle that occur during patient straining.

The Short Shaft Straight-In Bone Screw Fixation System is intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. It is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency, sling procedure for male stress urinary incontinence resulting from prostatectomy).

This 510(k) notification describes a device intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. The Short Shaft Straight-In Bone Screw Fixation System is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency, sling procedure for male stress urinary incontinence resulting from prostatectomy). The design and materials of the Short Shaft Straight-In and Straight-In systems are identical. The only difference is that the Inserter of the Short Straight-In device is shorter to serve the needs of users who prefer the maneuverability of a shorter device in open surgical procedures.

The Influence Clip System is indicated for permanent securing of two strands of surgical suture for soft tissue approximation in open or laparoscopic surgical procedures.

The Influence Clip System has two components, a suture clip and an applier. To fixate sutures, the stainless steel clip is inserted into the applier. Two strands of suture are threaded through the clip and the applier inserted into the trocar (if a laparoscopic procedure is performed). The applier's handle is then tightly squeezed which causes a rod within the applier's shaft to crimp the clip around the sutures. The sutures' ends are cut close to the clip (alternative version of applier with suture cutter may be used). The system is provided sterile and the applier is disposable, for single patient use.

The TriAngle Sling is intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.

The TriAngle Sling is a knitted patch fabric intended to be used as a sling in transvaginal sling procedures for the treatment of urinary stress incontinence.