NEWGEN/UNIVERSAL MANDIBULAR SYSTEM

K014263 · Stryker Instruments · JEY · Mar 8, 2002 · Dental

Device Facts

• Record ID: K014263
• Device Name: NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
• Applicant: Stryker Instruments
• Product Code: JEY · Dental
• Decision Date: Mar 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Leibinger NewGen System is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.

Device Story

The NewGen/Universal Mandibular System consists of bone plates and bone fixation fasteners (screws). It is used by surgeons for the stabilization and rigid fixation of mandibular fractures and during mandibular reconstruction procedures. The device provides mechanical support to bone segments to facilitate healing and structural integrity. It is intended for clinical use in a surgical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mandibular plate and screw system for bone fixation. Mechanical device; no software or electronic components.

Indications for Use

Indicated for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction in patients requiring surgical intervention.

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 System (K002619)

Submission Summary (Full Text)

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#### 8 2002 MAR 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:

NewGen/Universal Mandibular System

# General Information

| Proprietary Name: | NewGen/Universal Mandibular 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 x3295 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Robin L. Rowe<br>Regulatory Affairs Representative<br>Phone: [phone] x3295<br>Fax: [phone] |
| Summary Preparation Date: | November 22, 2000 |

#### Intended Use

The Stryker Leibinger NewGen System is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.

### Substantial Equivalence

# EQUIVALENT PRODUCTS:

The Leibinger® NewGen/Universal System is substantially equivalent to the NewGen System K002619 which is a legally marketed devices.

Robin J. Rowe
Regulatory Affairs Representative

Regulatory Affairs Representative December 20, 2001

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 8 2002

Ms. Robin L. Rowe Regulatory Affairs Stryker Instruments 4100 East Milham Avenue Kalamazo, Michigan 49001-6197

Re: K014263

Trade/Device Name: Newgen/Universal Mandibular System Regulation Number: 872.4760 Regulation Name: Bone Plates, Bone Fixation System Regulatory Class: II Product Code: JEY Dated: February 6, 2002 Received: February 7, 2002

Dear Ms. Rowe:

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.

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.

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Page 2 - Ms. Rowe

You must comply with all the Act's requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF R Pat 807), and 1007), and in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as set form in are quality signify systems (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 This letter will and w you to began mans and substantial equivalence of your device to 310(K) premierse notificate 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 If you desire up of CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally 21 OF 1 301) 594-4613. Additionally, for questions on the promotion and Office of Comphance are, 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 ulle Act may of occallied 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

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

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510(k) Number (if known):

Device Name: Newgen/Universal Madibular System

Indication For Use:

The Stryker Leibinger Newgen/Universal Mandibular System is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and reconstruction.

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

Concurrence of CDRH,Office of device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Svea Summo

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ivision Sign-Off ivision of Dental, Infection Control. nd General Hospital Devices 510(k) Number