IN-TAC BONE ANCHOR SYSTEM

K964953 · Influence, Inc. · HXJ · Feb 13, 1997 · Orthopedic

Device Facts

• Record ID: K964953
• Device Name: IN-TAC BONE ANCHOR SYSTEM
• Applicant: Influence, Inc.
• Product Code: HXJ · Orthopedic
• Decision Date: Feb 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4540
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The In-Tac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The In-Tac Bone Anchor 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 anchor and inserter; used for soft tissue fixation to pubic bone in transvaginal sling procedures. Inserter utilizes force-measuring spring to ensure anchor deployment only upon sufficient insertion force. Modifications from predicate include pre-threaded sutures, integrated retractable anchor shield, and stronger grade stainless steel inserter. Operated by physicians in clinical setting. Device provides mechanical fixation of tissue to bone; assists in treating stress urinary incontinence.

Clinical Evidence

Bench testing only; no clinical data provided. Biocompatibility testing confirmed material safety.

Technological Characteristics

Components: bone anchor and inserter. Materials: stainless steel (inserter), biocompatible materials. Features: pre-threaded sutures, retractable anchor shield, force-measuring spring for deployment control. Mechanical fixation principle.

Indications for Use

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

Regulatory Classification

Identification

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

Predicate Devices

• UroTac Bone Anchor System (K962372)

Submission Summary (Full Text)

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K964953

# Summary of Safety and Effectiveness Influence, Inc.'s In-Tac Bone Anchor System
510(k) Number K964953

FEB 13 1997

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 and CEO.

This 510(k) notification addresses modifications to the Influence, Inc. UroTac Bone Anchor System, a staple driver (21 CFR 888.4540) cleared under K962372. The modified device will be called the In-Tac Bone Anchor System. The modifications have been implemented to improve convenience of device use, and to provide enhanced material strength. In addition, the labeling has been modified to incorporate the indication for stress urinary incontinence resulting from intrinsic sphincter deficiency, and to provide instructions for use of the device in transvaginal sling procedures.

Like the UroTac Bone Anchor System, the In-Tac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The In-Tac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Like the UroTac Bone Anchor System, the In-Tac Bone Anchor System consists of two components: a bone anchor, and a bone anchor inserter. The In-Tac Bone Anchor System has the same overall design and technological characteristics as the configuration cleared under K962372, but implements the following changes: (1) the sutures will be provided pre-threaded for user convenience, and the retractable anchor shield will be incorporated into the disposable anchor assembly; (2) the inserter will be made from a stronger grade of stainless steel; and (3) the inserter incorporates a force measuring spring to ensure the anchors are deployed only if sufficient insertion force is applied.

All materials used in the In-Tac Bone Anchor System are commonly used in medical devices. Biocompatibility testing demonstrated that the materials are biocompatible. Bench testing demonstrated that the modifications made to the UroTac Bone Anchor System had no effect on device safety and effectiveness, and that its performance is substantially equivalent to the 510(k)-cleared configuration.

Based on the information provided, the In-Tac Bone Anchor System is substantially equivalent to the UroTac Bone Anchor System with respect to intended use, technological characteristics, and performance.

510(k) Notification for the In-Tac Bone Anchor System
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