LORENZ DISTRACTION SYSTEM

K992952 · Walter Lorenz Surgical, Inc. · MQN · Nov 19, 1999 · Dental

Device Facts

• Record ID: K992952
• Device Name: LORENZ DISTRACTION SYSTEM
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: MQN · Dental
• Decision Date: Nov 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lorenz Distraction System includes devices intended as a bone stabilizer, and distraction devices when correction of congenital deficiencies or post traumatic defects of oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction.

Device Story

Lorenz Distraction System consists of implantable distractors featuring drive screw mechanisms and connection plates; available in three configurations: without rails, with one rail, or with two rails. Devices function as bone stabilizers and distraction tools for gradual bone lengthening. Used in oral, cranial, and maxillo-facial surgery; operated by surgeons. Implanted to correct congenital deficiencies or post-traumatic bone defects. Mechanism involves mechanical distraction via drive screw to facilitate bone growth. Benefits include structural correction of skeletal defects. Potential risks include nonunion, device breakage, metal sensitivity, stress shielding, nerve damage, and infection.

Clinical Evidence

bench testing only

Technological Characteristics

Materials: Titanium or 316 LVM Stainless Steel. Design: Implantable distractor with drive screw mechanism and connection plates. Configurations: No rails, one rail, or two rails. Energy source: Mechanical (manual activation). Connectivity: None (standalone implant). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring gradual bone distraction for correction of congenital deficiencies or post-traumatic defects of the oral, cranial, and maxillo-facial regions, including mandible, alveolar ridge, palate, and symphysis areas.

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.

Submission Summary (Full Text)

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NOV 1 9 1999

K992952

## Summary of Safety and Effectiveness

Device Name: Lorenz Distraction System

Classification Name and Reference: Plate, Fixation, Bone; 87 HRS (21 FR 888.3030)

- Device Description: The Lorenz Distraction System includes several designs of implantable distractors which all have a drive screw mechanism and connection plates. Three basic types are included; without rails, with one rail, and with two rails. Each distractor is made of either Titanium or 316 LVM Stainless Steel materials.
- Intended Use: The Lorenz Distraction System includes devices intended as a bone stabilizer, and distraction devices when correction of congenital deficiencies or post traumatic defects of oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction.
- Potential Risks: The potential risks associated with the distraction system implants include but may not be limited to the following;
- 1. Nonunion, delayed union, or premature union may lead to breakage of the device.
- 2. Bending, loosening, or stripping of the threads or fracture of the device.
- 3. Metal sensitivity, or allergic reaction to a foreign body.
- 4. If device remains implanted, decrease in bone density due to stress shielding.
- 5. Pain, discomfort, or abnormal sensation due to the presence of the device.
- 6. Nerve damage due to surgical trauma.
- 7. Necrosis of bone.
- 8. Biomechanical complications after distraction due to positioning of the device.
- 9. Inadequate healing.
- 10. Other conditions brought on by the surgical procedure including skin irritation and infection.

Apart from these adverse effects there are always possible complications of any surgical procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the device.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three swooping lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 1999

Ms. Diana Preston Requlatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218

K992952 Re : Lorenz Distraction System Trade Name: Requlatory Class: II Product Code: MON August 30, 1999 Dated: Received: September 1, 1999

## Dear Ms. Preston:

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 against 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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

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Page 2 - Ms. Preston

obligation you might have under sections 531 through 542 of obligation for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberined in four for the equivalence of your device to a legally marketed predicate device results in a classification for your markees production 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 che pffice 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. Clatrid

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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510(k) Number (if known): Unknown K992952

Device Name: Lorenz Distraction System

- Intended Use: The Lorenz Distraction System includes devices intended as a bone stabilizer, and distraction devices when correction of congenital deficiencies or post traumatic defects of oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction.
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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_> (Per 21 FR 801.109)

OR

Susan Rusover

Division Sion-Off

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)