UROTAC BONE ANCHOR INSERTER

K962372 · Influence, Inc. · HXJ · Aug 19, 1996 · Orthopedic

Device Facts

• Record ID: K962372
• Device Name: UROTAC BONE ANCHOR INSERTER
• Applicant: Influence, Inc.
• Product Code: HXJ · Orthopedic
• Decision Date: Aug 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4540
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The UroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The UroTac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility.

Device Story

System consists of Nitinol bone anchor and stainless steel inserter; used for soft tissue-to-bone fixation during bladder neck suspension procedures. Anchor inserted into pubic bone medulla; locks upon application of pull force to attached USP Class I suture. Operated by surgeons in clinical/OR setting. Provides mechanical fixation to treat female stress urinary incontinence caused by urethral hypermobility. Benefits include secure soft tissue attachment to bone to restore urethral support.

Clinical Evidence

Bench testing only. Mean failure load tested per FDA Guidance Document for Testing Bone Anchor Devices (Draft Nov 1, 1993). Results demonstrate fixation strength substantially equivalent to Mitek GII predicate.

Technological Characteristics

Anchor material: Nitinol. Inserter material: Stainless Steel (ASTM F899-94). Mechanical fixation principle: anchor locks into pubic bone medulla via pull force on suture. Non-powered, manual surgical instrument.

Indications for Use

Indicated for female patients with stress urinary incontinence resulting from urethral hypermobility requiring soft tissue fixation to the pubic bone.

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

• MITEK GII Bone Anchor (K920213)
• MICROVASIVE (VESICA) Bone Anchor (K932925)

Submission Summary (Full Text)

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AUG 19 1996

Influence, Inc.
637 Steiner Street
San Francisco, California 94117
Tel. [phone]/Fax. [phone]
K962372
510(k) SUMMARY

Prepared: June 18, 1996.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Section 807.92.

## SUBMITTER

| NAME | Influence, Inc. |
| --- | --- |
| ADDRESS | 637 Steiner Street
San Francisco, California 94117 |
| TEL.#/FAX# | 415-552-4303 / 415-552-4309 |
| CONTACT | Peter A. Bick, MD
President |

NAME OF DEVICE
Consisting of:
- **UroTac Bone Anchor System**

TRADE NAME: UroTac Bone Anchor
COMMON NAME: Device for soft tissue to bone attachment.
CLASSIFICATION NAME: Staple, Fixation, Bone

TRADE NAME: UroTac Bone Anchor Inserter
COMMON NAME: Instrument used to insert bone anchor in desired situs.
CLASSIFICATION NAME: Surgical Instrument - Staple Driver

## PREDICATE DEVICE

- MITEK GII Bone Anchor (and accessories) (K920213)
- MICROVASIVE (VESICA) Bone Anchor (K932925)

## DESCRIPTION OF THE DEVICE

### FUNCTION

Fixation of non-absorbable suture below bone surface for soft tissue fixation.

UroTac Bone Anchor System
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# DEVICE DESIGN

Suture anchor constructed of Nitinol designed to lock into medulla of the pubic bone when pull force is applied to the suture attached to the anchor.

# MATERIAL

Anchor - Nitinol
Inserter - Stainless Steel (ASTM F899-94).

# INTENDED USE

The UroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The UroTac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility.

# COMPARISON TO PREDICATE DEVICES

The predicate device is the Mitek GII Anchor. Equivalent features include: use in connection with bladder neck suspension procedure to accomplish soft tissue fixation to the pubic bone; insertion of anchor into pubic bone; use of an inserter to set the anchor into the pubic bone; use of Nitinol as an essential material; use of USP Class I suture; and initial fixation strengths that are substantially equivalent. Microvasive’s Vesica Bone Anchor is a predicate device by virtue of the similarity of certain aspects of the bladder neck suspension procedure.

# DESCRIPTION OF NON CLINICAL TESTS

The mean failure load of the UroTac Bone Anchor, when pulled from pubic bone, has been tested in a manner consistent with the Guidance Document for Testing Bone Anchor Devices (Draft November 1, 1993).

# CONCLUSIONS FROM TESTS

The mean fixation strength of the device was demonstrated to be substantially equivalent to that of the Mitek predicate device. The tests did not yield any data suggesting safety or effectiveness issues which are other than those presented by the Mitek predicate device or the Microvasive bladder neck suspension procedure using the Vesica Bone Anchor.

UroTac Bone Anchor System
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