PRELOADED SOFT TISSUE ANCHOR

K963932 · Linvatec Corp. · MBI · Jun 20, 1997 · Orthopedic

Device Facts

• Record ID: K963932
• Device Name: PRELOADED SOFT TISSUE ANCHOR
• Applicant: Linvatec Corp.
• Product Code: MBI · Orthopedic
• Decision Date: Jun 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Preloaded Soft Tissue Anchor is a device used to attach soft tissue to bone fixation except anterior or posterior cruciate ligament repair or reconstruction. This device is indicated for bladder neck suspension for female urinary incontinence due to urethral hypermobility.

Device Story

Device consists of titanium alloy anchor preloaded with non-absorbable braided polyester suture; suture attached to threading wire via shrink tubing sleeve. During surgery, anchor is seated in driver; suture cut on device side of sleeve to release. Used for soft tissue-to-bone fixation, specifically bladder neck suspension. Operated by surgeons in clinical settings. Provides secure anchor point for sutures to treat urethral hypermobility; benefits patient by restoring bladder neck support.

Clinical Evidence

Bench testing only.

Technological Characteristics

Anchor: Titanium Alloy 6AI-4V-ELI. Suture: Non-absorbable braided polyester. Sleeve: Shrink tubing. Threading wire: 316 Stainless Steel. Sizes: 2.5mm to 5.2mm diameter. Sterilization: Gamma. Single-use.

Indications for Use

Indicated for bladder neck suspension in females with urinary incontinence due to urethral hypermobility.

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

• Mitek GII Anchor (K892126)
• Zimmer Statak Device (K926384)

Submission Summary (Full Text)

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K963932
Linvatec
JUN 20 1997

11311 Concept Boulevard Largo, Florida 33773 813 399-5334 Fax [phone]

Carol A. Weideman, Ph.D.
Manager, Regulatory
and Clinical Affairs

March 21, 1997

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Preloaded Soft Tissue Anchor, 510(k) Number # K963932.

## A. Submitter

Linvatec Corporation
11311 Concept Boulevard
Largo, Florida 33773-4908

## B. Company Contact

Carol A. Weideman, Ph.D.
Manager, Regulatory and Clinical Affairs

## C. Device Name

Trade Name: Revo®/Mini-Revo®
Common Name: Bone Screw
Classification Name: Soft tissue to bone fixation device

## D. Predicate/Legally Marketed Devices

Mitek GII Anchor
Zimmer Statak Device

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A Bristol-Myers Squibb Company

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Summary of Safety and Effectiveness
Preloaded Soft Tissue Anchor
510(k) # K963932
Page 2 of 3

## E. Device Description

The Preloaded Soft Tissue Anchor has an attached non-absorbable braided polyester suture through the eyelet. The suture is attached to a threading wire by a shrink tubing sleeve. Once the anchor is securely seated in the driver, the suture is cut on the device side of the shrink tubing and implantation can proceed.

The material used for this device is:

Anchor: Titanium Alloy
Suture: Non-absorbable braided polyester
Sleeve: Shrink tubing
Threading Wire: 316 Stainless Steel

## F. Intended Use

The Preloaded Soft Tissue Anchor is a device used to attach soft tissue to bone fixation except anterior or posterior cruciate ligament repair or reconstruction. This device is indicated for bladder neck suspension for female urinary incontinence due to urethral hypermobility.

The Preloaded Soft Tissue Anchor is available in sizes ranging from 2.5mm to 5.2mm diameter.

## G. Substantial Equivalence

The Preloaded Soft Tissue Anchor is substantially equivalent in function and intended use to the Mitek GII Anchor and the Zimmer Statak device. The anchors are all made of metal/metal alloy materials. Testing supports the equivalency to the predicate devices. The similarities/dissimilarities to the predicates are shown in the attached table.

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Summary of Safety and Effectiveness
Preloaded Soft Tissue Anchor
510(k) # K963932
Page 3 of 3

# SUBSTANTIAL EQUIVALENCE INFORMATION:

The similarities/dissimilarities to the predicate device/material are shown in the following table.

## CHART OF SIMILARITIES AND DISSIMILARITIES

| Company Name | Device Name | Intended Use | Material | Single-Use Reusable | Sizes |
| --- | --- | --- | --- | --- | --- |
| New Product
Linvatec:
Preloaded Soft Tissue Anchors | Revo/
Mini- Revo | Soft tissue to bone fixation
Bladder neck suspension for female urinary incontinence due to urethral hypermobility. | Titanium Alloy 6AI-4V-ELI
Suture: Non-absorbable
Braided Polyester | Single-use Gamma Sterilization Shipped sterile | Suture Anchor with Preloaded Suture Anchors: 2.5mm - 5.2mm
Suture: USP Sizes #0 to #2 |
| Predicate
Mitek:
Mitek GII Anchor
510(k) Number
K892126 | Mitek | Soft tissue to bone fixation - Bladder Neck Suspension | Titanium Alloy | Single-use Sterilization Method Unknown Shipped sterile | 2.4mm X 14mm |
| Predicate
Zimmer:
Statak Device
510(k) Number
K926384 | Statak/Mini
Statak | Soft tissue to bone fixation - Bladder Neck Suspension | Tivanium TI-6AI-4V Alloy
Suture: Non-absorbable
Braided Suture | Single-use Gamma Sterilization Shipped sterile | 2.5mm - 5.2mm diameter
Suture USP Sizes #0 to #2 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 20 1997

Carol A. Weideman, Ph.D.
Manager, Regulatory and Clinical Affairs
Linvatec Corporation
11311 Concept Boulevard
Largo, Florida 33773

Re: K963932
Trade Name: Revo® and Mini-Revo® Preloaded
Soft Tissue Anchor
Regulatory Class: II
Product Code: MBI
Dated: March 21, 1997
Received: March 24, 1997

Dear Dr. Weideman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical

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Page 2 - Carol A. Weideman, Ph.D.

Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the *Federal Register*. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Linvatec

11311 Concept Boulevard, Largo, FL 34643 813 392-6464

March 21, 1997

510(k) Number (if known): K963932

Device Name: PRELOADED SOFT TISSUE ANCHOR

Indications for Use:

**Bladder Neck Suspension**

The Linvatec Preloaded Soft Tissue Anchor is indicated for bladder neck suspension for femine urinary incontinence due to urethral hypermobility.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ OR Over-the-Counter Use ☐
(Per 21 CFR 801.109)


(Optional Format 1-2-96)

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A Bristol-Myers Squibb Company