IMTEC BONE TAC

K973180 · Imtec Corp. · DZL · Nov 18, 1997 · Dental

Device Facts

• Record ID: K973180
• Device Name: IMTEC BONE TAC
• Applicant: Imtec Corp.
• Product Code: DZL · Dental
• Decision Date: Nov 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IMTEC Bone Tac System is designed to stabilize a Barrier Membrane onto a region of cortical plate. This may be used in craniofacial, maxillofacial or mandibular bone. Considerations such as quality of bone, bone type, functional loads exerted, general patient health and others should be carefully evaluated prior to use.

Device Story

IMTEC Bone Tac is a titanium alloy fixation device used to stabilize barrier membranes against cortical bone during surgical procedures. The system includes bone tacs, a seating instrument, and a mallet. The clinician places the tac through the barrier membrane into the bone using the seating instrument and a mallet strike. In dense cortical bone, a pilot drill hole may be required. The device is used in clinical settings by surgeons. It provides mechanical stabilization of the membrane to facilitate healing. Post-procedure, radiographs document tac position. Tacs are intended for single use and may be removed via surgical scalpel or elevator if necessary.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Materials: Titanium 6Al-4V ELI (tacs), 303 Stainless Steel (instrument handles), Polycarbonate (holder cover). Principle: Mechanical bone fixation via barbed metallic tack. Form factor: Low-profile head with stabilization barb. Sterilization: Non-sterile (requires user sterilization). Connectivity: None.

Indications for Use

Indicated for stabilization of barrier membranes on cortical bone plates in craniofacial, maxillofacial, or mandibular regions. Contraindicated in patients with vascular impairment, systemic/local infection, diabetes, radiation therapy, steroid therapy, anticoagulant therapy, clotting disorders, or other systemic/metabolic limitations compromising healing.

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

• Interpore International, IMZ Bone Tack System (K952167)
• Interpore International, IMZ Membrane Tack System (K960945)

Submission Summary (Full Text)

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# K973180

#### 510 (k) SUMMARY

#### SUBMITTED BY:

M. K. Patterson, Jr., PhD Sr. Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401 [phone]

F.D.A. Registration Number: 1645158 Owner / Operator Number: 9003407

Date Submitted: August 20, 1997

### CLASSIFICATION/COMMON OR USUAL NAME/DEVICE NAME:

Classification Name: Smooth or threaded metallic bone fixation fastener (ref: 21 CFR 888.3040); Product Code: DZL Common/Usual Name: Bone Tack, Bone Screw or Bone Fixation Device. Proprietary Name: IMTEC Bone Tac

#### PREDICATE DEVICE:

Interpore International, IMZ Bone Tack System, K952167 Interpore International, IMZ Membrane Tack System, K960945

#### DEVICE DESCRIPTION:

The IMTEC Bone Tac is fabricated of titanium alloy and has a thin low profile head and a barb at the tip for stabilization. It is designed to stabilize guided tissue membranes during the healing process by providing an attachment mechanism to the adjacent bone at the surgical site. The device will be marketed non-sterile.

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## INDICATIONS FOR USE:

The IMTEC Bone Tac System is designed to stabilize a Barrier Membrane onto a region of cortical plate. This may be used in craniofacial, maxillofacial or mandibular bone. Considerations such as quality of bone, bone type, functional loads exerted, general patient health and others should be carefully evaluated prior to use.

## PRINCIPLES OF OPERATION:

1. An aseptic technique is required for predicable success.

2. The tacs and instrumentation are provided NON-STERILE and must be appropriately sterilized prior to use.

3. Remove the cap from the seating instrument. Firmly press the seating instrument onto the head of the desired length tac in the tac holder. This will purchase the tac to be carried to the placement site. Seat the tac through the barrier material only with the tip of the seating instrument perpendicular to the bone surface or the tac may be damaged. Placement should be accomplished with a single firm tap on the base of the seating instrument with the mallet. To disengage the tac, roll the seating instrument to one side. If the tac is not completely seated after the first mallet strike, place the protective cap on the seating instrument and complete the process by tapping on the seating instrument with the cap positioned against the tac head. The seating instrument may be damaged if it is repeatedly struck with the tac in the "held" position.

4. Repeat this process until the barrier is firmly anchored. Always store the seating instrument with the cap in place. Otherwise, it may become distorted and not able to purchase the tac head.

5. A pilot drill hole may be required in areas of dense cortical bone. The twist drill required for this process is delicate and must be used with a cautious and light pressures to prevent fracture. A pilot hole should be placed through laminar bone when it is being used as the barrier.

6. Suture the soft tissue in the usual manner when the surgical procedure is complete. Every effort should be made to assure primary closure of all areas.

7. Radiographs should be taken to document the number and position of the tacs. This information should also be noted in the patient's record.

8. In instances where tac removal is required, after normal surgical exposure the tacs may be dislodged by using a surgical scalpel, periosteal elevator or other similar thin flat instrument. The tacs should be removed, inventoried and discarded. REUSE IS NOT RECOMMENDED. The surgical site is now resutured.

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# CONTRAINDICATIONS:

General patient evaluation is critical prior to any surgical procedure. Contraindications include, but are not limited to, vascular impairment, systemic or local infection, diabetes, radiation, steroid, or anticoagulant therapy, clotting disorders or other systemic or metabolic limitations which would compromise healing.

## COMPLICATIONS:

Complications include those associated with any osseous surgical procedure and an esthetic usage. Type and severity of complications may indicate tac removal at the discretion of the clinician.

## MATERIALS OF CONSTRUCTION:

| Bone Tac | Titanium 6Al-4V ELI |
|------------------------------------|-------------------------------------|
| Bone Tac Instrument | |
| Handle | 303 Stainless Steel |
| Tip and Cap | Titanium 6Al-4V |
| Autoclavable Tac Holder | |
| Stainless Steel w/Titanium Inserts | 303 Stainless Steel/Titanium 6Al-4V |
| Cover | Polycarbonate (Autoclavable) |
| Bone Tac Mallet | |
| Handle and Head | Stainless Steel |

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

The design, material, configuration,method of sterilization and other technological characteristics of IMTEC Bone Tac are similar to the currently marketed predicate devices.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1997

M.K. Patterson, Jr., Ph.D. Sr. Vice President Regulatory Affairs Imtec Corporation 2401 North Commerce Ardmore, Oklahoma 73401

Re: K973180 Trade Name: Imtec Bone Tac Requlatory Class: İI Product Code: DZL Dated: August 20, 1997 Received: August 25, 1997

Dear Dr. Patterson:

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 aqainst 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. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical 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

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Pageg 2 - Dr. Patterson

through 542 of the Act for devices under the Electronic chrough 942 or the not ro- rouisions, or other Federal laws or requlations.

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 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,

K. Clatton

thy 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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510(k) Number (if known):

IMTEC BONE TAC SYSTEM Device Name:

Indications For Usc:

i

The IMTEC Bone Tac System is designed to stabilize a Barrier Membrane onto a region of cortical plate. This may be used in craniofacial, maxillofacial or mandibular bone. Considerations such as quality of bone, bone type, functional loads exerted, general patient health and others should be carefully evaluated prior to use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


| (Division Sign-Off) |
|-----------------------------------------|
| Division of General Restorative Devices |

| 510(k) Number | K973180 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
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