BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM

K013672 · Azary Technologies, LLC · JEY · Apr 8, 2002 · Dental

Device Facts

• Record ID: K013672
• Device Name: BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM
• Applicant: Azary Technologies, LLC
• Product Code: JEY · Dental
• Decision Date: Apr 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject device is intended to be used as a bone stabilizer and lengthening device for the correction of congenital deficiencies or post-traumatic defects of the oral cavity (mandible, ramus, ridge, and palate).

Device Story

Implantable distraction system for bone lengthening/stabilization in oral cavity; includes transpalatal, transmandibular, and mandibular dynamic osteosynthesis units. Device components (fixation units, screws, distraction units) surgically implanted; patient performs manual activation post-operatively using provided spanner to achieve distraction. Used by clinicians for correction of congenital or post-traumatic defects. Benefits include structural bone correction and stabilization.

Clinical Evidence

No clinical data provided. Substantial equivalence based on identical material composition, indications for use, and technological approach to predicate devices, supported by successful prior clinical usage in Europe.

Technological Characteristics

Materials: Titanium Alloy Grade 2 and 5 per ASTM F-67 and ASTM F-136. Components: Transpalatal, transmandibular, and mandibular dynamic osteosynthesis units. Mechanism: Intra-oral bone-borne mechanical distraction via manual spanner activation. Non-sterile supply.

Indications for Use

Indicated for patients requiring bone stabilization or lengthening due to congenital deficiencies or post-traumatic defects of the oral cavity, including mandible, ramus, ridge, and palate.

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

• Howmedica Leibinger Guerrero-Bell Distractor (or Dynaform) (K972166)
• Martin Zurich Distraction System (K010139)
• Medartis MODUS Mandibular Reconstruction System (K992682)

Submission Summary (Full Text)

{0}------------------------------------------------

FDA 510(k) Premarket Notification
Surgi-Tec - Bruges Distraction - Anchoring - Osteosynthesis System

K013672

510 (k) Summary [as required by 21 CFR 807.92]

# Date Prepared [21 CFR 807.92(a)(1)]

November 1, 2001

#### Submitter's Information [21 CFR 807.92(a)(1)]

Surgi-Tec S.A. C/o Joseph Azary Azary Technologies LLC P.O. Box 2156 Huntington, CT. 06484

#### Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

The device trade names are:

- Bruges Distraction Anchoring Osteosynthesis System �
### Predicate Device [21 CFR 807.92(a)(3)]

The subject device is substantially equivalent to the following devices:

| Subject Device Name | 510k |
|------------------------------------------------------------|---------|
| Howmedica Leibinger Guerrero-Bell Distractor (or Dynaform) | K972166 |
| Martin Zurich Distraction System | K010139 |
| Medartis MODUS Mandibular Reconstruction System | K992682 |

#### Description of the Device [21 CFR 807.92(a)(4)]

The subject device includes several different designs of implantable distractors intended for bone lengthening or stabilization. The subject device is not supplied sterile. The subject device consists of:

| Transpalatal Distractor TPB | Transmandibular Distractor<br>TMD | Mandibular Distraction Dy-<br>namic Osteosynthesis MD-<br>DOS |
|-----------------------------|-----------------------------------|---------------------------------------------------------------|
| Module Size #1 (1 - 21mm) | Vertical Footplates with rods | Posterior Fixation Unit (PFU) |
| Module Size# 2 (16 - 31mm) | Osteosynthesis Screws | Fixation Screws |
| Module Size# 3 (22 - 49mm) | | Distraction Unit (DU) |
| Module Size# 4 (26 - 59mm) | | Anterior Fixation Unit (AFU) |
| Abutment Plate | | Spacer |
| Osteosynthesis Screws | | |

The subject device requires patient activation at specified times post-operatively using a provided spanner.

{1}------------------------------------------------

The device is composed of Titanium Allov Grade 2 and 5 per ASTM F-67 and ASTM F-136 requirements.

#### Intended Use [21 CFR 807.92(a)(5)]

The subject device is intended to be used as a bone stabilizer and lengthening device for the correction of congenital deficiencies or post-traumatic defects of the oral cavity (mandible, ramus, ridge, and palate).

#### Technological Characteristics [21 CFR 807.92(a)(6)] and Performance Data [21 CFR 807.92(b)(1))

The subject device has identical material composition and indications for use as the predicate devices. The subject device is based on a similar technological approach by using intra-oral bone-borne titanium components to stabilize and/or lengthen the oral cavity (mandible, ramus, ridge, and palate). Additionally, this device has been successfully used in Europe for several years.

#### Conclusion [21 CFR 807.92(b)(3)]

The subject device has identical indications for use and similar technological characteristics as the predicate devices. The subject device is composed of Titanium, which is a material used in the predicate devices, as well as a material that has been used successfully in a variety of dental and medical implants over the last several decades. Lastly, clinical usage has found the subject device to produce satisfactory results and function safely as a medical device.

We conclude that the subject device is as safe and effective as the predicate device and does not raise any new issues of safety or effectiveness.

{2}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joseph M. Azary Azary Technologies LLC P.O. Box 2156 Huntington, Connecticut 06484

Re: K013672

Trade/Device Name: Surgi-Tec S.A. Bruges Distraction-Anchoring-Osteosynthesis Systems Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 25, 2002 Received: May 14, 2002

Dear Mr. Azary:

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 requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

BB

Image /page/2/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

{3}------------------------------------------------

Page 2 - Mr. Azary

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,

Timothy A. Ulatowski

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

Enclosure

{4}------------------------------------------------

#### FDA 510(k) Premarket Notification

Surgi-Tec - Bruges Distraction - Anchoring - Osteosynthesis System

# 5 10(k) Number (if known): KOJ3672

Device Name: Surgi-Tec S.A. Bruges Distraction - Anchoring - Osteosynthesis Systems

Indications For Use: The subject device is intended to be used as a bone stabilizer and lengthening device for the correction of congenital deficiencies or post-traumatic defects of the oral cavity (mandible, ramus, ridge, and palate).

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

# Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Susan Riance

(Division Sign-Off) Division of Dental, Infection Control, and Gsneral Hospital Devices 10156 F10tk) Number __

1-1