UNIVERSAL CMF SYSTEM

K022185 · Stryker Instruments · JEY · Dec 17, 2002 · Dental

Device Facts

• Record ID: K022185
• Device Name: UNIVERSAL CMF SYSTEM
• Applicant: Stryker Instruments
• Product Code: JEY · Dental
• Decision Date: Dec 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.

Device Story

Universal CMF System consists of bone plates and bone fixation fasteners. Device used for osteotomy, stabilization, and rigid fixation of cranio-maxillofacial (CMF) fractures and reconstruction. System provides mechanical support to bone segments during healing process. Operated by surgeons in clinical/surgical settings. Device functions as passive implantable hardware; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cranio-maxillofacial plate and screw system. Mechanical fixation device. Materials are biocompatible metals typical for orthopedic/CMF fixation. Standalone implantable hardware. No energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring osteotomy, stabilization, and rigid fixation of cranio-maxillofacial fractures and reconstruction.

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

• NewGen Mandibular System (K014263)
• NewGen System (K002619)
• Steinhauser Titanium Mini Bone Plates & Screws (K862482)
• Wurzburg Titanium Mini Bone Plates and Bone Screws (K854886)
• Synthes Midfacial System (K953806)
• MODUS Titanium Osteosynthesis System (K993862)
• Dumbach Titanium Mesh Implant System (K862532)

Submission Summary (Full Text)

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# DEC 1 7 2002

KODASS

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:

Universal CMF System

#### General Information

| Proprietary Name: | Universal CMF System |
|--------------------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | Bone Plates<br>Bone Fixation Fasteners |
| Proposed Regulatory Class: | Class II |
| Device Classification: | 76 JEY<br>87 HWC |
| Submitter: | Stryker Leibinger<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>616-323-7700 x4226 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Wade T. Rutkoskie<br>Regulatory Affairs Associate<br>Phone: [phone]<br>Fax:<br>616-323-4215 |
| Summary Preparation Date: | June 28, 2002 |

#### Intended Use

The Stryker Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.

#### Substantial Equivalence

#### EQUIVALENT PRODUCTS:

The Stryker® Leibinger Universal CMF System is substantially equivalent to legally marketed K014263 NewGen Mandibular System, K002619 NewGen System , K862482 Steinhauser Titanium Mini Bone Plates & Screws, K854886 Wurzburg Titanium Mini Bone Plates and Bone Screws, K953806 Synthes Midfacial System, K993862 MODUS® Titanium Osteosynthesis System and K862532 Dumbach Titanium Mesh Implant System.

Nudy T. Rutkuski

Wade T. Rutkoskie Regulatory Affairs Associate

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2002

Mr. Wade Rutkoskie Regulatory Affairs Associate Stryker Instruments Leibinger Division 4100 East Milham Avenue Kalamazoo, Michigan 49087

Re: K022185

Trade/Device Name: Universal CMF System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: September 30, 2002 Received: October 4, 2002

Dear Mr. Rutkoskie:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (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 approval 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 - Mr. Rutkoskie

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 vou 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). 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,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 1 of 1

510(k) Number (if known)

Device Name: Universal CMF System

Indication For Use:

The Stryker® Leibinger Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction. 1 .

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

Concurrence of CDRH, Office of device Evaluation (ODE)

| Prescription Use | <div style="display:flex; align-items:center;"> ✓ </div> | or | Over-The-Counter Use | |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|----|----------------------|--|
| (per 21 CFR 801.109) | | | | |
| | Susan Runne | | | |
| (Division Sign-Off) | (Optional Format 1-2-96) | | | |
| Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices | | | | |
| 510(k) Number: | K022155 | | | |