CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE

K062572 · Custom Scientific · MQN · May 11, 2007 · Dental

Device Facts

• Record ID: K062572
• Device Name: CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE
• Applicant: Custom Scientific
• Product Code: MQN · Dental
• Decision Date: May 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Craniotech Bone Transport Reconstruction Plate (BTRP) system includes devices intended as a bone stabilizer, lengthening and/or transport device when correction of congenital or developmental bone deficiencies or post-traumatic or post-surgical defects of the mandible (including ramus, body, alveolar ridge, symphisis) and mid-face bones require gradual distraction.

Device Story

The Craniotech BTRP is a mechanical bone stabilizer and distractor used for gradual bone lengthening or transport in the mandible and mid-face. The system consists of a reconstruction plate and screws made of TiAl6V4 titanium alloy, combined with a stainless steel bone transport unit, activation screw, and flexible cable. It is intended for use by clinicians to address bone deficiencies or defects. The device functions through mechanical distraction to facilitate bone growth or transport. It is used in a clinical setting to assist in reconstructive procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: TiAl6V4 titanium alloy (reconstruction plate and screws), stainless steel (bone transport unit, activation screw, flexible cable). Mechanical distraction principle. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring gradual distraction for correction of congenital or developmental bone deficiencies, or post-traumatic or post-surgical defects of the mandible (ramus, body, alveolar ridge, symphisis) and mid-face bones.

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

• Zurich Distraction System (K010139)

Submission Summary (Full Text)

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## 510(k) SUMMARY

| | | MAY 1 1 2007 | | | | |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--|--|--|--|
| Submitter Name: | Custom Scientific | | | | | |
| Submitter Address: | 7021 Haverford Drive | | | | | |
| | Dallas, TX 75214 | | | | | |
| Contact Person: | Mr. Timothy Mulone | | | | | |
| Phone Number: | 214.343.3688 | | | | | |
| Fax Number: | 214.503.8192 | | | | | |
| Date Prepared: | August 31, 2006 | | | | | |
| Device Trade Name: | Craniotech Bone Transport Reconstruction Plate (BTRP) | | | | | |
| Device Common Name: | External Mandibular Fixator and/or Distractor | | | | | |
| Classification Number: | 21 CFR 872.4760 | | | | | |
| Classification Name: | Bone Plate | | | | | |
| Product Code: | MQN | | | | | |
| Predicate Device: | K010139; Zurich Distraction System; KLS-Martin L.P. | | | | | |
| Statement of Intended<br>Use: | The Craniotech Bone Transport Reconstruction Plate (BTRP) system includes devices intended as a bone stabilizer, lengthening and/or transport device when correction of congenital or developmental bone deficiencies or post-traumatic or post-surgical defects of the mandible (including ramus, body, alveolar ridge, symphisis) and mid-face bones require gradual distraction. | | | | | |
| Device Description: | The device contains a reconstruction plate and screws of TiAl6V4 titanium alloy, and a stainless steel bone transport unit, activation screw and flexible cable. | | | | | |
| Comparison to the<br>Predicate Devices: | Based upon the intended use, design, materials, and the testing conducted, it can be concluded the BTRP is substantially equivalent to the predicate device in terms of intended use, safety and effectiveness. | | | | | |

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Public Health Service

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, symbolizing service to the nation. 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

## MAY 1 1 2007

Craniotech ACR Device, LLC C/O Ms. Patsy J. Trisler 5600 Wisconsin Avenue, # 509 Chevy Chase, Maryland 20815

Re: K062572

Trade/Device Name: Craniotech Bone Transport Reconstruction Plate Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: May 4, 2007 Received: May 7, 2007

Dear Ms. Trisler:

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.

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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. 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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K062572

Device Name:

Craniotech Bone Transport Reconstruction Plate

Indications for Use:

The Craniotech Bone Transport Reconstruction Plate (BTRP) system includes devices intended as a bone stabilizer, lengthening and/or transport device when correction of congenital or developmental bone deficiencies or post-traumatic or post-surgical defects of the mandible (including ramus, body, alveolar ridge, symphisis) and mid-face bones require gradual distraction.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

Susan Runner

on of Anesthesiology, General Hospital

K Number: K062572