THE AUTOTAC SYSTEM

K993493 · BioHorizons Implant Systems, Inc. · DZL · Jan 7, 2000 · Dental

Device Facts

• Record ID: K993493
• Device Name: THE AUTOTAC SYSTEM
• Applicant: BioHorizons Implant Systems, Inc.
• Product Code: DZL · Dental
• Decision Date: Jan 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AUTOTAC System™ is intended to fixate or stabilize bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity or in other clinical situations that require membrane use/fixation.

Device Story

The AUTOTAC System is a mechanical fixation device used by clinicians in the oral cavity to stabilize barrier membranes during bone or tissue regeneration procedures. The system consists of a Tissue Tack fabricated from a bioresorbable polymer, featuring a flat head and two circular ribs on the shaft to prevent slippage. The tack is deployed to anchor membranes to resident or adjacent bone/tissue. The device is provided sterile for single use. It functions as a mechanical fastener to maintain membrane position, facilitating predictable clinical outcomes in guided bone/tissue regeneration. No software or electronic components are involved.

Clinical Evidence

The device was evaluated through animal studies and laboratory bench testing. Mechanical tests confirmed pull-out strength equivalence to predicate devices. In-vitro testing verified performance under shear loading. No clinical human trial data was required or presented.

Technological Characteristics

The device is a mechanical fixation tack fabricated from a bioresorbable polymer. It features a round, flat head and two circular ribs on the shaft for retention. The device is provided sterile and is for single use only. No energy source, software, or electronic components are utilized.

Indications for Use

Indicated for patients requiring fixation or stabilization of bioresorbable or non-bioresorbable barrier membranes for tissue or bone regeneration in the oral cavity or other clinical sites requiring membrane fixation.

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Predicate Devices

• Biovision GMBH LEADfix Bioresorbable Membrane Pin System
• 3i BIO TACK

Submission Summary (Full Text)

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K993493

BioHorizons Implant Systems, Inc. 510(k) Notification 10/13/99

N - 7 2000

# 510(k) Summary of Safety and Effectiveness

Proprietary Name

The AUTOTAC System™

Common Name

Screw, tack, membrane fixation pin

Classification Name Intraosseous fixation screw

Classification

Class II

#### Official Contact

BioHorizons Implant Systems, Inc. One Perimeter Park South Suite 230 South Birmingham, AL 35243 [phone] Fax [phone]

#### Device Description

The AUTOTAC System™ consists of components and instruments designed to fixate and stabilize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity or in other clinical situations that require membrane use/fixation. The system provides an anchoring mechanism for the membranes to resident and adjacent bone or tissue at the surgical site. The Tissue Tack is fabricated from a well-known bioresorbable polymer and has a round, flat head, and two circular ribs on the shaft to prevent the implanted tack from slipping out. The tack is provided sterile and is not intended to be resterilized by the user.

### Product Evaluation

The AUTOTAC System™ was evaluated by consulting clinicians in animal tests and laboratory studies and found to effective for fixation of barrier membranes without new health risks and is a predictable means to achieve clinical success in guided bone and/or tissue regeneration.

Mechanical tests demonstrated that the pull-out strength of the AUTOTAC System™ was equivalent to the predicate devices. Furthermore, the resorbable membrane will not deleteriously affect the implanted tack under shear loading based on in-vitro mechanical tests.

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BioHorizons Implant Systems, Inc. 510(k) Notification 10/13/99

# Indications for Use

The AUTOTAC System™ is intended to fixate and stablize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue in the oral cavity or in other clinical situations that require membrane use/fixation.

## Substantial Equivalence Information

The AUTOTAC System™ is substantially equivalent to all features which could affect safety or effectiveness to the Biovision GMBH LEADfix Bioresorbable Membrane Pin System and the 3i BIO TACK due to the similarities in tack design and intended use.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that they appear to be emerging from or connected to each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**JAN - 7 2000**

Mr. Winston D. Greer Vice-President of Operations Bio-Horizons Implant Systems, Incorporated One Perimeter Park South Suite 230 South Birmingham, AL 35243

K993493 Re : The AUTOTAC System™ Trade Name: Class: II Product Code: DZL October 13, 1999 Dated: Received: October 15, 1999

Dear Mr. Greer:

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 The general controls provisions of the Act 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 Title 21, Parts 800 to 895. A Federal Regulations, substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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

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Page 2 - Mr. Greer

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 acborizon in four in four 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 requlation (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,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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BioHorizons Implant Systems, Inc. 510(k) Notification 10/13/99

Page 1 of 1

510(k) Number (if known):

Device Name: _____ The AUTOTAC System™

Indications for Use:

8 ..... The AUTOTAC System™ is intended to fixate or stabilize bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity or in other clinical situations that require membrane use/fixation.

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(per 21 CFR 801.109) | <div style="display:flex; flex-direction:column;"><div>✓</div><div>Suam Rann</div></div> |
|------------------------------------------|------------------------------------------------------------------------------------------|
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OR

| Over-the-Counter Use | |
|----------------------|--|
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(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | 1993493 |
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