THE AUTOTAC SYSTEM

K011675 · BioHorizons Implant Systems, Inc. · DZL · Jun 22, 2001 · Dental

Device Facts

• Record ID: K011675
• Device Name: THE AUTOTAC SYSTEM
• Applicant: BioHorizons Implant Systems, Inc.
• Product Code: DZL · Dental
• Decision Date: Jun 22, 2001
• Decision: SESE
• Submission Type: Special
• 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

AUTOTAC System consists of tissue tacks and instruments for membrane fixation; used in oral cavity for tissue/bone regeneration. Tack fabricated from bioresorbable polymer; features round flat head and two circular ribs on shaft to prevent slippage. System provides anchoring mechanism to resident/adjacent bone or tissue. Used by clinicians in surgical settings. Mechanical design ensures pull-out and shear strength sufficient to prevent premature membrane movement. Provided sterile via gamma or ETO; single-use only.

Clinical Evidence

Bench testing only. Mechanical studies demonstrated pull-out and shear strength sufficient to prevent premature movement of periodontal membranes. Evaluation by consulting clinicians confirmed effectiveness for membrane fixation without new health risks.

Technological Characteristics

Bioresorbable polymer tissue tack; round flat head with two circular ribs on shaft. Sterilized via gamma or ETO. Mechanical fixation principle.

Indications for Use

Indicated for fixation and stabilization of bioresorbable and non-bioresorbable barrier membranes for tissue and/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

• K993493

Submission Summary (Full Text)

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Special 510(k): Device Modification Summary of Safety and Effectiveness

## Proprietary Name

JUN 2 2 2001

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 by either gamma or ETO sterilization and is not intended to be re-sterilized by the user.

#### Product Evaluation

The AUTOTAC System™ tissue tack was evaluated by consulting clinicians and laboratory studies and found to be 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 and shear strength of the AUTOTAC System™ tissue tack is sufficient to prevent premature movement of the periodontal membrane.

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# Indications for Use

The AUTOTAC System™ is intended to fixate and stabilize bioresorbable and non-bioresorbable barrier membranes used for regeneration of tissue in the and normbloroonbable ituations that require membrane use/fixation.

# Substantial Equivalence Information

The AUTOTAC System™ ETO-sterilized tissue tack is substantially equivalent to all features which could affect safety or effectiveness to the equivalorit to all foutures thk (K993493) due to the similarities in tack design, material and intended use.

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JUN 2 2 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald E. Dalton Director of Quality Assurance Biohorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230, South Birmingham, Alabama 35243

Re : K011675 The Autotac System Trade/Device Name: 872.4880 Requlation Number: Requlatory Class: II Product Code: DZL Dated: May 29 ,2001 Received: May 30, 2001

### Dear Mr. Dalton:

We have reviewed your Section 510(k) notification of incent to we have reviewed your boosed above and we have determined the market the devisorially equivalent (for the indications for device is subscanciary orgal to legally marketed predicate use stated in the chorobase, commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enactment date of chassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the reacrar tone, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual provisions of the ing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II if your device is class III (Premarket Approval), it may (Special Concessional controls. Existing major be subject to Back addroundevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with bubbeancearly odaManufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Forch In the Qualition (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug chrough periodic go mill verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. accron: "Illude device in the Eederal Register. Please note:

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Page 2 - Mr. Dalton

this response to your premarket notification submission does this response to your premarket have under sections 531
not affect any obligation you might have under the Flectronic not affect any obligation you mages under the Electronic through 542 of the Act for devices and 1requlations.

This letter will allow you to begin marketing your device as This lecter will affow your over of your dovice The FDA described in your 510(K) prematic normalice to a legally
finding of substantial equivalence of your device for your finding of substantial equivailies of yolassification for your marketed predicate device resures in a crabbed.
device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling If you desire specific advice rollibers the office of regulation (21 crk Farc ove anase contact the Office of
vitro diagnostic devices), please contact the for questi vitro diagnostic devices), preab otionally, for questions on
Compliance at [phone]. Additionally, plaase contact Compliance at (301) 554 inin. In your device, please contact
the promotion and advertising of your device, algo, please no the promotion and advertising of your actives in the office of the Office the orress on and the misbranding by reference to premarket notification" (21CFR 807.97) . Other general premarker notification (arch over the Act may be information on your responsible and Manufacturers Assistance obtained from the DIVISION OF Bildir Handsons.
at its toll-free number [phone] or [phone] or at its internet address

1ts Incernet addross
"http://www.fda.gov/cdrh/dsma/dsmamajn.html".

Sincerely yo

A. Ulatowski Timothy 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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(011675 510(k) Number (if known): _

The AUTOTAC System™ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runze

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use (per 21 CFR 801.109) Over-the-Counter Use

OR