UNIVERSAL NEURO SYSTEM

K031659 · Stryker Instruments · JEY · Sep 10, 2003 · Dental

Device Facts

• Record ID: K031659
• Device Name: UNIVERSAL NEURO SYSTEM
• Applicant: Stryker Instruments
• Product Code: JEY · Dental
• Decision Date: Sep 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker® Leibinger Universal Neuro System is a low-profile plate and screw system intended for osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction of non-load bearing areas.

Device Story

Stryker Leibinger Universal Neuro System consists of low-profile bone plates and bone fixation fasteners (screws). Device used by surgeons for stabilization and rigid fixation during craniofacial procedures, including osteotomy, craniotomy, and fracture reconstruction in non-load bearing areas. System provides mechanical support to bone segments to facilitate healing and structural integrity post-surgery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design comparison to predicate devices.

Technological Characteristics

Low-profile bone plates and screws for craniofacial fixation. Mechanical fixation system. Materials and design characteristics are consistent with predicate bone plate and fastener systems.

Indications for Use

Indicated for patients requiring osteotomy, craniotomy, stabilization, and rigid fixation of craniofacial fractures and reconstruction of non-load bearing areas.

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

• Universal CMF System (K022185)
• Osteomed M 3 System (K924138)
• Osteomed 1.2 mm Autodrive Screw System (K023260)
• Synthes Low Profile Neuro System (K022012)

Submission Summary (Full Text)

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K03/659

SEP. 1 0 2003

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:

Stryker® Leibinger Universal Neuro System

### General Information

| Proprietary Name: | Stryker® Leibinger Universal Neuro 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>269-323-4226 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Wade T. Rutkoskie<br>Associate Manager RA QA<br>Phone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | May 20, 2003 |

### Intended Use

The Stryker® Leibinger Universal Neuro System is a low-profile plate and screw system intended for osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction.

## Substantial Equivalency Information

The Stryker® Leibinger Universal Neuro System is substantially equivalent to legally marketed K022185 Universal CMF System, K924138 Osteomed M 3 System, K023260 Osteomed 1.2 mm Autodrive Screw System, and K022012 Synthes Low Profile Neuro System.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

SEP 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Wade T. Rutkoskie Associate Manager RA QA Stryker Instruments Leibinger Division 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K031659

Trade/Device Name: Sryker® Leibinger Universal Neuro System Bone Plates and Bone Fixation Fasteners Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: June 20, 2003 Received: June 17, 2003

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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 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,

Susan Runs

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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Page 1 of 1

510(K) Number (if known): K031659

Device Name: Stryker® Leibinger Universal Neuro System

Indication for Use:

The Stryker® Leibinger Universal Neuro System is a low-profile plate and screw system intended for osteotomy, craniotomy, stabilization and rigid fixation of craniofacial fractures and reconstruction of non-load bearing areas.

Kein Mulvey for MSA

y, General Hospital, n of Anesthesiolo ion Control, Den

510(k) Number: K031659

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

Or

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|----------------------|---|
| (per 21 CFR 801.109) | |

Over-The-Counter Use

(Optional Format 1-2-96)