IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW

K970292 · Influence, Inc. · MBI · Apr 23, 1997 · Orthopedic

Device Facts

• Record ID: K970292
• Device Name: IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW
• Applicant: Influence, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Apr 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The In-Fast Bone Screw System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Story

System consists of bone screw with attached polypropylene suture and inserter tool. Used for soft tissue fixation to pubic bone during cystourethropexy or transvaginal sling procedures. Inserter positioned pervaginally; screw tip driven into bone cortex; rotating shaft threads screw into pubic bone. No pre-drilling or soft tissue dissection required. Physician-operated in clinical setting. Provides fixation strength for bladder neck suspension; enables surgical correction of incontinence; benefits patient by restoring urethral support.

Clinical Evidence

Bench testing only. No clinical data provided. Performance demonstrated via mechanical testing of fixation strength and biocompatibility testing of materials.

Technological Characteristics

System includes small diameter bone screw/anchor and inserter. Screw threaded with polypropylene suture. Materials are biocompatible and commonly used in medical applications. Mechanical fixation via threaded insertion into pubic bone cortex. Manual operation.

Indications for Use

Indicated for female patients with stress urinary incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• UroTac Bone Screw System (K962372)
• Mitek GII Anchor (K920213)
• Vesica Suture Anchor System (K932925)
• Questus Polyester Soft Tissue Anchor System (K953264, K963200)

Submission Summary (Full Text)

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K970292

# 510(k) Summary of Safety and Effectiveness Influence, Inc.'s In-Fast Bone Screw System
## 510(k) Number K97-0292

This 510(k) notification is submitted by Influence, Inc., 601 Montgomery Street, Suite 845, San Francisco, California 94111. The contact person is Peter A. Bick, President & CEO.

This 510(k) notification describes a bone screw and bone screw inserter intended for soft tissue fixation to the pubic bone by means of bone screws with attached suture. The In-Fast Bone Screw System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The In-Fast Bone Anchor System is substantially equivalent to Influence, Inc.'s UroTac Bone Screw System cleared under K962372. The mechanical properties and technical procedure of the two systems are almost identical. In both devices, fixation of soft tissue to bone is accomplished by a sharp tipped small diameter bone screw/anchor anchor threaded with polypropylene suture which is inserted pervaginally through soft tissue and into the pubic bone, without drilling holes or performing soft tissue dissection. The screw/anchor is loaded into an inserter which is positioned in the vagina. Pulling force is applied on the user handle to pass the screw/anchor’s tip into the bone cortex. The inserter’s safety lock is released and screw/anchor is inserted into the prescribed depth in the pubic bone. In the In-Fast system, the screw is threaded into the bone by the inserter’s rotating shaft. In the UroTac system, the anchor is pushed into the bone by the spring-loaded inserter. A cystourethropexy procedure is then performed which is identical for both the UroTac and In-Fast systems. Alternately, a transvaginal sling procedure may be performed using the In-Fast which is substantially equivalent to the in situ sling technique used in conjunction with the Vesica Suture Anchor System (K932925, Boston Scientific Corp., by its Microvasive division, the successor-in-interest to Vesica Medical, Inc., formerly Vesitec).

The Mitek GII Anchor (K920213), used in bladder neck suspensions, and the In-Fast bone screw have been proven to provide substantially equivalent fixation strength. The Questus™ Polyester Soft Tissue Anchor System (K953264 and K963200, Wright Medical Technologies, Inc.) is also used in bladder neck suspensions and closely resembles the screw used in the In-Fast system.

All materials used in the In-Fast Bone Screw System are either commonly used in medical applications or have been proven to be biocompatible through biocompatibility testing. Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to a 510(k) cleared device.

Based on the information provided, the In-Fast Bone Screw System is substantially equivalent to the UroTac System with respect to intended use, technological characteristics, labeling, performance and surgical procedure. Also based on the

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information provided, the In-Fast Bone Screw System is substantially equivalent to the Mitek GII Anchor with respect to intended use, technological characteristics and performance; the Vesica Suture Anchor System with respect to intended use, technological characteristics, performance and its use in the vaginal sling procedure; and the Questus™ Polyester Suture Soft Tissue Anchor with respect to intended use, technological characteristics and performance.