KLS-MARTIN MMF SCREW

K980760 · KLS-Martin L.P. · DZL · Dec 21, 1999 · Dental

Device Facts

• Record ID: K980760
• Device Name: KLS-MARTIN MMF SCREW
• Applicant: KLS-Martin L.P.
• Product Code: DZL · Dental
• Decision Date: Dec 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KLS-Martin MMF Screw is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.

Device Story

KLS-Martin MMF Screw provides temporary occlusal and fracture stabilization for maxilla and mandible fractures. Applied by clinicians prior to or after fracture exposure. Device functions as a fixation screw to stabilize bone segments. Benefits include rapid stabilization of fractures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fixation screw for maxillomandibular stabilization. Mechanical device; no software or electronic components.

Indications for Use

Indicated for maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Predicate Devices

• Leibinger IMF Screw (K963030)

Submission Summary (Full Text)

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K980760

:

DEC 2 1 1999

## 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:<br>Fax: | 813-376-4154<br>813-376-7186 |
| Contact Person: | Ed Ransom | |
| Date of Summary: | February 25, 1998 | |
| Trade Name: | KLS-Martin MMF Screw | |
| Classification Name: | Screw, Fixation | |
| Predicate Device: | Leibinger IMF Screw: K963030 | |
| Device Description/<br>Comparison: | The KLS-Martin MMF Screws provide temporary<br>occlusal and fracture stabilization which can be<br>achieved within a matter of minutes. These screws<br>may be applied prior to or after exposure of the<br>fracture. | |
| Intended Use: | The KLS-Martin MMF Screw is intended for use in<br>maxillomandibular fixation to provide stabilization of<br>fractures of the maxilla, mandible, or both. | |

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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 consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines or strokes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1999

Mr. Arthur J. Ward Medical Device Consultant Regulatory & Marketing Services, Incorporated 3234 Ella Lane New Port Richey, Florida 34655

Re: K980760 KLS-Martin MMF Screw Trade Name: Requlatory Class: II Product Code: DZL November 7, 1999 Dated: November 9, 1999 Received:

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, 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, 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 Requlations, Title 21, Parts 800 to 895. ದ 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 regulation 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 - Mr. Ward

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.

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 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 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,

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): ____________________________________________________________________________________________________________________________________________________

KLS-Martin MMF Screw Device Name:

Indications For Use:

The KLS-Martin MMF Screw is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.

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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 Runser

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