MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES

K994154 · KLS-Martin L.P. · JEY · Feb 15, 2000 · Dental

Device Facts

• Record ID: K994154
• Device Name: MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES
• Applicant: KLS-Martin L.P.
• Product Code: JEY · Dental
• Decision Date: Feb 15, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KLS-Martin Molina Distractors are external Distractors for bone elongation. It is used for the correction of asymmetric mandibular deficiencies and mandibular hypoplasia. The devices are external and are anchored to the mandible by external fixation pins.

Device Story

External mandibular fixation device for bone elongation; consists of uni-directional and bi-directional distractors with anchoring pins. Used for correction of asymmetric mandibular deficiencies and mandibular hypoplasia. Device anchored to mandible via external fixation pins. Operates as mechanical distraction system. Primary difference from predicate is material composition (titanium alloy vs. stainless steel).

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material comparison to predicate device.

Technological Characteristics

External bone distractor system; materials: titanium alloy; form factor: uni-directional and bi-directional distractors with external fixation pins.

Indications for Use

Indicated for bone elongation in patients with asymmetric mandibular deficiencies and mandibular hypoplasia. External device anchored to the mandible via external fixation pins.

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

• Molina Distractor Wells Johnson (K945500)

Submission Summary (Full Text)

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FEB 1 5 2000

K994154

## 510(K) SUMMARY (as required by 807.92(c))

| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)<br>3234 Ella Lane<br>New Port Richey, FL 34655 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | 727-376-4154 |
| Fax: | 727-376-7186 |
| Contact Person: | Art Ward |
| Date of Summary: | December 2,1999 |
| Trade Name: | MOD Line of Molina Distractors |
| Classification Name: | Plate, Bone |
| Predicate Device: | K945500 Molina Distractor Wells Johnson |
| Device Description/Comparison: | The KLS-Martin Molina Distractor is a mandibular<br>fixation device consisting of Uni-directional and<br>Bi-directional distractors and pins for anchoring. The<br>product is identical to the predicate device except for<br>material which is a titanium alloy rather than stainless<br>steel. |
| Intended Use: | The KLS-Martin Molina Distractors are external<br>Distractors for bone elongation. It is used for the<br>correction of asymmetric mandibular deficiencies and<br>mandibular hypoplasia. The devices are external and<br>are anchored to the mandible by external fixation pins. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, which is a common symbol associated with the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2000

KLS-Martin L.P. c/o Mr. Arthur Ward Regulatory & Marketing Sevices, Incorporated 3234 Ella Lane New Port Richey, Florida 34655

Re : K994154 Trade Name: Mod Line of Molina Distractors, 51-600 Series Regulatory Class: II Product Code: JEY December 2, 1999 Dated: Received: December 9, 1999

Dear Mr. Ward:

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) 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Ward

the Federal Register. Please note: this response to your premarket notification submission does not affect any premailon 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.

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,

K. Ulatowski

Timothy A. Ulatowski

Diredtor 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):

KLS-Martin Molina Distractor Device Name:

Indications For Use:

The KLS-Martin Molina Distractors are intended for use as external distractors for bone elongation. It is used for the correction of asymmetric mandibular deficiencies and mandibular hypoplasia. The devices are external and are anchored to the mandible by external pins.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Susan Roane

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