SYNTHES (USA) AUTOMATED TACK DRIVER

K021382 · Synthes (Usa) · JEY · May 16, 2002 · Dental

Device Facts

• Record ID: K021382
• Device Name: SYNTHES (USA) AUTOMATED TACK DRIVER
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: May 16, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Resorbable Tack System is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethmoidal and infraorbital areas, comminuted fractures of the craniofacial skeleton. Synthes Resorbable Tack System is not intended for use in the mandible or other full load-bearing situations, for areas with active infection or for patient conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.

Device Story

Synthes Automated Tack Driver is a manual surgical accessory for the Synthes Resorbable Tack System; used for craniofacial bone fixation. Device incorporates a compression spring mechanism to provide controlled, repeatable insertion force for resorbable tacks into pre-drilled bone holes. Upon release of the spring, the device automatically drives the tack into the bone. Operated by surgeons in clinical/OR settings. Provides consistent mechanical force for tack placement; improves procedural control compared to previous manual drivers. Benefits include reliable stabilization of craniofacial fractures and reconstructive sites.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual surgical instrument; incorporates a compression spring mechanism for automated tack insertion. Designed for use with resorbable tacks for craniofacial bone fixation. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring fixation, alignment, and stabilization of craniofacial bone fractures (e.g., naso-ethmoidal, infraorbital, frontal sinus wall, midfacial) and reconstructive procedures. Contraindicated for use in the mandible, full load-bearing situations, areas with active/latent infection, or patients with compromised blood supply or insufficient bone quality/quantity.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

• Synthes Resorbable Tack System, Self-Retaining Tack Driver (K000560)

Submission Summary (Full Text)

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MAY 1 6 2002

K021382

### 3. 510(k) Summary:

| Submitter | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Bonnie Smith<br>[phone] |
| Name of the Device | Synthes Automated Tack Driver<br>(An accessory to Synthes Resorbable Tack System) |
| Predicate Device | Synthes Resorbable Tack System, Self-Retaining Tack Driver -<br>K000560 |
| Device Description | Synthes Automated Tack Driver is designed for use with Synthes<br>Resorbable Tacks. Resorbable Tacks provide fixation and aid in the<br>alignment and stabilization of craniofacial bones when used in<br>conjunction with Resorbable Fixation System plates and meshes. To<br>facilitate tack insertion into a predrilled hole in bone, the Self-<br>Retaining Tack Driver previously cleared has been modified for<br>more controlled and repeatable insertion force. A compression<br>spring has been added to the design, which upon release allows<br>automatic tack insertion into a pre-drilled hole in bone. |
| Intended Use | Synthes Resorbable Tack System is intended for fractures of the<br>craniofacial skeleton including, but not limited to, comminuted<br>fractures of the naso-ethmoidal and infraorbital areas, comminuted<br>fractures of the frontal sinus wall, and midfacial fractures; and<br>reconstructive procedures of the midface or craniofacial skeleton.<br>Synthes Resorbable Tack System is not intended for use in the<br>mandible or other full load-bearing situations, for areas with active<br>infection or for patient conditions including blood supply.<br>limitations, insufficient quantity or quality of bone, or latent infections. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle, there is a stylized image of three human profiles facing to the right, stacked one behind the other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 6 2002

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P. O. Box 1766 Paoli, Pennsylvania 19301

Re: K021382

Trade/Device Name: Synthes (USA) Automated Tack Driver Regulation Number: 872.4760 and 882.5330 Regulation Name: Bone Plate and Preformed Nonalterable Cranioplasty Plate Regulatory Class: II Product Code: JEY and GXN Dated: April 30, 2002 Received: May 2, 2002

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other

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Page 2 - Ms. Smith

requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Patricia Cicerata Kfor

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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K021382

#### 2. Indications for Use

#### Special 510(k) Device Modification

INTENDED USE STATEMENT

510(k) Number (if known):

Device Name:

Indications

K021382

Synthes Automated Tack Driver (An accessory to Synthes Resorbable Tack System)

Synthes Resorbable Tack System is intended for fractures of the craniofacial skeleton including, but not limited to, comminuted fractures of the naso-ethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall, and midfacial fractures; and reconstructive procedures of the midface or craniofacial skeleton.

Synthes Resorbable Tack System is not intended for use in the mandible or other full load-bearing situations, for areas with active infection or for patient conditions including blood supply limitations, insufficient quantity or quality of bone, or latent infections.

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Subject (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices XIXI3K

510(k) Number ________________________________________________________________________________________________________________________________________________________________

(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) | OR | Over-the-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

CONFIDENTIAL Synthes (USA) Special 510(k): Automated Tack Driver for Synthes Resorbable Tack System