MODUS SAGITTAL SPLIT PLATE

K993862 · The Straumann Co. · JEY · Dec 29, 1999 · Dental

Device Facts

• Record ID: K993862
• Device Name: MODUS SAGITTAL SPLIT PLATE
• Applicant: The Straumann Co.
• Product Code: JEY · Dental
• Decision Date: Dec 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MODUS® Titanium Osteosynthesis System is intended for use in oral, maxillofacial surgery such as: trauma; surgical correction of dentofacial deformities; reconstructive surgery; orthognathic and craniofacial surgery. The MODUS® Sagittal Split Plate with slider is used for stabilization of mandibular bone segments after a sagittal split osteotomy.

Device Story

MODUS® Titanium Osteosynthesis System is a mechanical fixation device used in oral and maxillofacial surgery. It consists of U-shaped sagittal split plates (0.7 mm thick, 6 or 8 screw holes) and a 10 mm diameter slider. The device is used by surgeons to stabilize mandibular bone segments following sagittal split osteotomy. It provides rigid fixation to support bone healing and structural alignment in trauma, reconstructive, orthognathic, and craniofacial procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed from CP Grade 1 titanium (plate) and Grade 4 CP titanium (slider) meeting ASTM F67. U-shaped plate design, 0.7 mm thickness, 31.65 mm to 52.65 mm length range. Mechanical fixation device.

Indications for Use

Indicated for patients undergoing oral, maxillofacial, orthognathic, or craniofacial surgery, including trauma, reconstructive surgery, and correction of dentofacial deformities. Specifically used for stabilization of mandibular bone segments following sagittal split osteotomy.

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

• MODUS® System Plates and Mesh (K946165)
• Synthes 2.0 mm Sagittal Split Plates (K981890)
• Synthes (MMFS) - Adjustable Sagittal Split Plate (K964328)

Submission Summary (Full Text)

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K993862

DEC 2 9 1999

### ATTACHMENT 8 - 510(k) Summary

#### 1. Applicant's Name and Address

Straumann USA (on behalf of Medartis GmbH) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 Telephone Number: 781-890-0001 781-890-6464 Fax Number: Contact Person: Linda Jalbert, Director of Regulatory Affairs

#### 2. Name of the Device

| Trade Name: | MODUS® Titanium Osteosynthesis System<br>Sagittal Split Plate and Slider |
|----------------------|--------------------------------------------------------------------------|
| Common Name: | Craniomaxillofacial Fixation Plates |
| Classification Name: | Bone plate, 21 CFR 872.4760, Class II |

### Legally Marketed Devices to which Equivalence is Claimed (Predicate 3. Devices)

MODUS® System Plates and Mesh (K946165) Synthes 2.0 mm Sagittal Split Plates (K981890) Synthes (MMFS) - Adjustable Sagittal Split Plate (K964328)

#### 4. Description of the Device

The MODUS® System sagittal split plate with slider has a U-shaped design. It is available in two configurations, with six or eight screw holes. The plate is composed of CP Grade 1 titanium. The plate has a thickness of 0.7 mm and is available in a range of lengths of 31.65mm to 52.65 mm. The slider is 10 mm in diameter and is composed of Grade 4 CP titanium meeting ASTM F67.

#### న. Intended Use of the Device

The MODUS® Titanium Osteosynthesis System is intended for use in oral, maxillofacial surgery such as: trauma; surgical correction of dentofacial deformities; reconstructive surgery; orthognathic and craniofacial surgery. The MODUS® Sagittal Split Plate with slider is used for stabilization of mandibular bone segments after a sagittal split osteotomy.

#### ર. Basis for Substantial Equivalence

The MODUS® Sagittal Split Plate with Slider and Screws are substantially equivalent to previously cleared MODUS® craniofacial plates and mesh, and to Synthes sagittal split-fix plates in terms of intended use, design, and material.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 1999

Ms. Linda Jalbert Director, Requlatory Affairs The Straumann Company Reservoir Place 1601 Trapelo Road Waltham, MA 02451

Re: K993862

> Trade Name: MODUS® Titanium Osteosynthesis System Regulatory Class: II Product Code: JEY Dated: November 12, 1999 Received: November 15, 1999

Dear Ms. Jalbert:

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, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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

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Page 2 - Ms. Jalbert

the Federal Register. Please note: this response to your premarket notification submission does not affect any 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 requlation (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,

Gerald W Shipp

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

Enclosure

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# Indications for Use Statement

# Device Name:

MODUS® Titanium Osteosynthesis System - Sagittal Split Plate and Slider

Indications for Use:

The MODUS® Titanium Osteosynthesis System is intended for use in oral maxillofacial surgery such as: trauma; surgical correction of dentofacial deformities; reconstructive surgery; orthognathic and craniofacial surgery. The Sagittal Split Plate with slider is used for stabilization of mandibular bone segments after a sagittal split osteotomy.

**Prescription Use**
**(Per 21 CFR 801.109)**

Angela Blackwell for MSK

Division of Dental, Infection Control, and General Hospital 510(k) Number .

MODUS Sagittal Split Plate 510(k)