LORENZE EXTERNAL MANDIBULAR DISTRACTOR

K031696 · Walter Lorenz Surgical, Inc. · MQN · Jun 17, 2003 · Dental

Device Facts

• Record ID: K031696
• Device Name: LORENZE EXTERNAL MANDIBULAR DISTRACTOR
• Applicant: Walter Lorenz Surgical, Inc.
• Product Code: MQN · Dental
• Decision Date: Jun 17, 2003
• 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

Lorenz External Mandibular Distractor is an external fixator for mandibular bone lengthening. Device frame consists of two threaded rails (one straight, one angled) connected by a locking collar with a central ball joint, allowing three-dimensional contouring to match facial curvatures. Straight rail provides up to 40mm distraction; angled rail provides up to 30mm. Device is non-sterile, single-use. Used by surgeons to treat mandibular asymmetry and hypoplasia. Clinical benefit derived from gradual bone lengthening; requires patient adherence to postoperative care. Risks include device fracture, nonunion, nerve damage, infection, and soft tissue complications.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design and technological characteristics.

Technological Characteristics

External fixator; two threaded rails (straight and angled); locking collar with ball joint for 3D contouring; non-sterile; single-use.

Indications for Use

Indicated for mandibular bone lengthening in patients with mandibular asymmetry and hypoplasia. Contraindicated in patients with active infection, sepsis, foreign body sensitivity, limited blood supply, insufficient bone quality/quantity, latent infection, bone disorders limiting bone generation, or mental/neurologic conditions preventing adherence to postoperative care.

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

• K992873

Submission Summary (Full Text)

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JUN 1 7 2003

K031696

### Summary of Safety and Effectiveness

Lorenz External Mandibular Distraction Device Name:

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

### Contraindications:

- 1. Active infection and sepsis.
- 2. Foreign body sensitivity. Where material sensitivity is suspected, testing is to be completed prior to implantation.
- Patients with limited blood supply, insufficient quantity or quality of bone, or latent 3. infection.
- 4. Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions.
- 5. Bone disorders which limit bone generation.

K992873

(SAME AS ORIGINAL SUBMISSION KOOL238) "The distractor frame is Description: 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."

Sterility Information: The places and screws will be marketed as non-sterile, single use devices

### Possible risks:

- Bending, loosening of bone screws, K-wire, or ball joint, stripping of threaded rails, or 1. fracture of the device.
- 2. Nonunion, delayed union, or premature union may lead to breakage of the implant.
- 3. Metal sensitivity, or allergic reaction to a foreign body.
- 4. Pain, discomfort or abnormal sensations due to the presence of the device.
- ર . Nerve damage due to surgical trauma.
- 6. Other conditions brought on by the surgical procedure including skin irritation and infection.
- 7. Biomechanical complications due to positioning of the device.

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- 8. Poor done formation. Osteoporosis, Osteolysis, Osteomvelitis. inhibited revascularization, or infection can cause loosening, bending, cracking or fracture of the device.
- 9. Necrosis of bone or soft tissue.
- Tension of the soft tissue depending on the speed of distraction and quality of the soft 10. tissues and therefore irritation and/or atrophy.
- 11. Inadequate healing.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 7 2003

Ms. Kim Reed Sr. Regulatory Specialist Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218-2480

Re: K031696

Trade/Device Name: Lorenz External Mandibular Distractor Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Codes: MON Dated: May 30, 2003 Received: June 05, 2003

Dear Ms. Reed:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 annroval 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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Page 2 - Ms. Kim Reed

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 (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), 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) you may obtain. 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,

Simon Russe

Susan Runner, DDS, MA Interim 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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# STATEMENT OF INDICATIONS FOR USE

510(k) Number:

K031696

Device Name: 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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OR

Over-The-Counter-Use (Optional Format 1-2-96)

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Kain Muluy for M.D.
(Division Sign-or)

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K031696

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