LORENZ EXTERNAL MANDIBULAR DISTRACTOR

K992873 · Walter Lorenz Surgical, Inc. · MQN · Sep 17, 1999 · Dental

Device Facts

• Record ID: K992873
• Device Name: LORENZ EXTERNAL MANDIBULAR DISTRACTOR
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: MQN · Dental
• Decision Date: Sep 17, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lorenz External Mandibular Distractor is an external fixator used for mandibular bone lengthening. It is used in treatment of mandibular asymmetry and hypoplasia.

Device Story

External mandibular distractor used for bone lengthening in patients with mandibular asymmetry or hypoplasia. Device consists of two threaded rails (straight and angled) connected by a central locking collar with a ball joint, allowing three-dimensional contouring to match facial curvature. Bone screws or K-wires are inserted percutaneously into the mandible and secured to the frame via clamps. Adjustments to the distraction distance (up to 40mm straight, 30mm angled) are performed intra-operatively or post-operatively by the surgeon. The device provides mechanical distraction to stimulate bone growth. Used in a clinical setting by surgeons.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

External fixator frame; materials: stainless steel (rails/ball joint), Ti-6Al-4V (locking collar), 316 LVM stainless steel (bone screws/K-wires), hard coat anodized aluminum (clamp). Biplanar design with two threaded rails (M6 x 1 thread, 1mm pitch). Mechanical distraction principle. Percutaneous bone fixation via taper trocar tipped screws or K-wires. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring mandibular bone lengthening for the treatment of mandibular asymmetry and hypoplasia.

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

• Lorenz Mandibular Distractor (K955640)

Submission Summary (Full Text)

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

K992873

:・

# Summary of Safety and Effectiveness

Device Name: Lorenz External Mandibular Distractor

Predicate Device: Lorenz Mandibular Distractor, 510(k) number K955640

Classification Name: External Mandibular Fixator and/or Distractor

Device Product Code and Regulation Number: MQN, 21 CFR 872.4760

#### Intended use:

The Lorenz External Mandibular Distractor is an external fixator used for mandibular bone lengthening. It is used in treatment of mandibular asymmetry and hypoplasia.

#### Device Description:

The distractor frame is comprised of two threaded rails, a longer straight rail, and a shorter, angled rail to accommodate the anatomic angles of the mandible. These two rails are connected with a locking collar placing the ball joint in the center allowing three dimensional contouring to match facial curvatures. This biplanar distractor allows for up to 40mm distraction with the straight rail, and up to 30mm distraction with the angled rail.

Bone screws (or K-wire) are inserted percutaneously into the bone and attached to the distractor frame with a clamp.

The frame is locked by set screws which tighten and thereby lock the ball joint and rails in place. Adjustments can be made intra-operatively or post-operatively.

#### Device Modifications:

#### 1. Materials:

- . Predicate distractor K955640:
- 1. external distractor frame- hard coat anodized aluminum
- 2. bone fixation pins-Ti-6Al-4V
- 3. lengthening screw- stainless steel
- . Modified distractor:
- 1. external distractor frame (rails and ball joint)- stainless steel
- 2. ball locking collar-Ti-6Al-4V
- 3. bone screws/k-wire-316 LVM Stainless Steel
- 4. clamp-hard coat anodized aluminum

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

Device Modifications cont.

- 2. Device:
- . Predicate distractor K955640:
- unilateral distraction with ball joint 1.
- 4mm screw with 0.5mm pitch 2.
- 3. 2.7mm percutaneous bone fixation pins
- . Modified distractor:
- Biplanar distraction with ball joint 1.
- 6mm screw (rail) M6 x 1 thread (1mm pitch) 2.
- 3.0/2.5mm taper trocar tipped bone fixation screws 3. 2.5/2.0mm taper trocar tipped bone fixation screw
- 1.6 & 2.0mm K-wire

### 3. Design:

- . Predicate distractor
- 1. The frame has a ball joint at one end and a lengthening screw at opposite end.
- . Modified distractor
- Frame has two threaded rails, a longer straight ball rail, and a shorter, angled 1. rail to accommodate the anatomic angles of the mandible. The two rails are connected with a locking collar placing the ball joint in the center.
- Bone screws/K-wire attach to frame by clamps. 2.

## Potential Risks:

.

- 1. Bending, loosening of bone screws, k-wire, or ball joint, stripping the threads, or fracture of the device.
- 2. Nonunion, delayed union, or premature union.
- 3. Metal sensitivity or allergic reaction.
- 4. Pain, discomfort or abnormal sensations due to the presence of the device.
- 5. Nerve damage.
- 6. Other conditions brought on by the surgical procedure including skin irritation and infection.
- 7. Biomechanical complications due to improper positioning of the device.

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 1999

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

K992873 Re : Lorenz External Mandibular Distractor Trade Name: Requlatory Class: II Product Code: MON Dated: Auqust 23, 1999 Received: August 26, 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 requlations 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) 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 requlatory 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 obligation you might have under sections 531 through 542 of

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

Page 2 -Ms. Preston

the Act 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 findinq 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 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 entiled, "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,

Timothy A. Ulatowski

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

Enclosure

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

Page __ 1_ of __1

510(k) Number (if known): unknown

:

Device Name: Lorenz External Mandibular Distractor

Indications For Use: The Lorenz External Mandibular Distractor is an external fixator used for mandibular bone lengthening. It is used in treatment of mandibular asymmetry and hypoplasia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K992873

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_

(Optional Format 1-2-96)