LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM

K982906 · Walter Lorenz Surgical, Inc. · MQN · Nov 12, 1998 · Dental

Device Facts

• Record ID: K982906
• Device Name: LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: MQN · Dental
• Decision Date: Nov 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lorenz Intraoral Linear Mandibular Distraction System is intended for use in the mandibulo as mandibular deficiencies or post traumatic defects require gradual bone distraction.

Device Story

The Lorenz Intraoral Linear Mandibular Distraction System is a surgical device used to treat mandibular deficiencies or post-traumatic defects. It facilitates gradual bone lengthening through distraction osteogenesis. The system is implanted intraorally by a surgeon to provide mechanical stabilization and controlled distraction of the mandible. By gradually separating bone segments, the device promotes new bone formation in the gap. It is used in a clinical/surgical setting to address structural jaw abnormalities, potentially improving patient function and aesthetics.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Intraoral linear distraction system for mandibular bone lengthening. Mechanical device; no software or electronic components. Materials and specifications not detailed in the provided text.

Indications for Use

Indicated for patients requiring gradual bone distraction for mandibular deficiencies or post-traumatic defects.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 1998

Ms. Diana Preston Requlatory Affairs Specialist Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218-2480

Re : K982906 Lorenz Intraoral Linear Mandibular Trade Name: Distraction System Regulatory Class: Unclassified Product Code: MQN August 17, 1998 Dated: Received: August 18, 1998

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, Druq, 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, qood 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Preston

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,

Patricia Cuesta Hoffer

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

Device Name: Lorenz Intraoral Linear Mandibular Distraction System

The Lorenz Intraoral Linear Mandibular Indications For Use: The Lorenz Incraorar Lintended for use in the Distraction bystem lizer and bone lengthening mandibilo as mandibular deficiecies or post traumatic defects require gradual bone distraction.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Suoen Puaser
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital , Infect 510(k) Number

OR

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)