STRYKER MMF SCREW

K050535 · Stryker Instruments · DZL · Mar 17, 2005 · Dental

Device Facts

• Record ID: K050535
• Device Name: STRYKER MMF SCREW
• Applicant: Stryker Instruments
• Product Code: DZL · Dental
• Decision Date: Mar 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker® MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.

Device Story

The Stryker® MMF Screw is a bone screw designed for temporary maxillomandibular fixation. It provides indirect stabilization for maxillary and mandibular fractures in patients with sufficient occlusion. The device is used by clinicians in a surgical or clinical setting to facilitate fracture management. It functions as a mechanical fixation component to stabilize bone segments during the healing process.

Technological Characteristics

Bone screw for intraosseous fixation. Class II device (21 CFR 872.4880). Mechanical fixation device.

Indications for Use

Indicated for temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible, or both, in patients with sufficient occlusion.

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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# MAR 17 2005

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# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:

Stryker® MMF Screw

### General Information

| Proprietary Name: | Stryker® MMF Screw |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Small Bone Screws |
| Proposed Regulatory Class: | Class II |
| Device Classification: | 76 DZL<br>21 CFR 872.4880, Intraosseous Fixation<br>Screw or Wire |
| Submitter: | Stryker®<br>Instruments<br>Leibinger Micro Implants<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>877-534-2464 x 4062 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Nathan M. Miersma<br>Regulatory Affairs Representative<br>Phone: [phone] x 4062<br>Fax: [phone] |

#### Intended Use

The Stryker® MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.

### Substantial Equivalence

EQUIVALENT PRODUCTS:

The Stryker® MMF Screw is substantially equivalent to the Leibinger® IMF Screw, K963030 (Howmedica Leibinger).

Rothschild

Nathan M. Miersma Regulatory Affairs Representative Stryker® Instruments Leibinger Micro Implants Division

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

MAR 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker® Instruments Mr. Nathan M. Miersma Regulatory Affairs Representative Stryker Instruments, Leibinger Division 4100 East Avenue Kalamazoo, Michigan 49001

Rc: K050535

Trade/Device Name: Stryker® MMF Screw Regulation Number: 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: March 1, 2005 Received: March 2, 2005

Dear Mr. Miersma:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reveal above and have determined the device is substantially equivalent (for the referenced above and have and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device micisate conmisive prior to read have been reclassified in accordance with the provisions of Amendinens, or to do roos and have a ct (Act) that do not require approval of a premarket the I cucur I vou, Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, listing of devices, good manufacturing practice, requirements prohibitions against misbranding and adulteration.

If your device is classified (sec above) into either class II (Special Controls) or class III If your device is classified (See h additional controls. Existing major regulations affecting (1 Mrx), it may of subject to the 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 - Mr. Miersma

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualles of a substantines with other requirements
mean that FDA has made a determination that your device the Federal occepcios mean that FDA has made a decemination and regulations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by seciences and of the Act of ally rederal statues and reguirements, including, but not limited to: registration protice You must colliply with an the Act 5 read 801); good manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); grood manufacturing practice and if the (21 CFR i art 607), labeling (21 CFR (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality byections (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) This letter will anow you to begin maneraling of substantial equivalence of your device to a premarket notification. THE FDT matts 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), If you desire specific advice to: your as 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 from the may obtain 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/industry/support/index.html.

Sincerely yours,

Susan Punnes

S. Chia-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosurc

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## Indications for Use

510(k) Number (if known):

K050535

Device Name: Stryker® MMF Screw

Indications For Use:

The Stryker® MMF Screw is intended for use as a bone screw in temporary maxillomandibular fixation, providing indirect stabilization of fractures of the maxilla, mandible or both, where is sufficient occlusion.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ramsey

(RN)

Microbiology, General Hospital
Infection Control, Dental Devices

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