SYNTHES CRANIAL PLATES

K020087 · Synthes (Usa) · JEY · Feb 20, 2002 · Dental

Device Facts

• Record ID: K020087
• Device Name: SYNTHES CRANIAL PLATES
• Applicant: Synthes (Usa)
• Product Code: JEY · Dental
• Decision Date: Feb 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Cranial Plates are intended for use in selective trauma of the craniofacial skeleton; craniofacial surgery; reconstructive surgery; and selective orthognathic surgery of the maxilla and chin.

Device Story

Synthes Cranial Plates are titanium plates designed for fixation in craniofacial procedures. Used by surgeons in clinical settings to stabilize bone segments following trauma or during reconstructive and orthognathic surgeries. Plates are provided in various shapes to accommodate anatomical requirements of the maxilla and chin. Device functions as a mechanical fixation system to support bone healing and structural integrity. Clinical benefit includes stabilization of the craniofacial skeleton.

Technological Characteristics

Titanium bone plates; various shapes for craniofacial fixation; Class II device (872.4760, 882.5250).

Indications for Use

Indicated for patients requiring surgical fixation for selective trauma of the craniofacial skeleton, craniofacial surgery, reconstructive surgery, or orthognathic surgery of the maxilla and chin.

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.

Submission Summary (Full Text)

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# FEB 2 0 2002

#### Summary of Safety and Effectiveness Information 3.

Ko20087

Sponsor

Company Contact

Name of the Device

Device Classification(s)

Substantial Equivalence

Device Description

Indications

Material

Synthes (USA) 1690 Russell Road Paoli, PA 19301

Matthew M. Hull [phone] ext. 7191

Synthes Cranial Plates

Class II, §872.4760 - Plate, Fixation, Bone Class II, §882.5250 - Burr Hole Cover

Documentation was provided which demonstrated the Synthes Documentation was provided which equivalent to other legally marketed devices.

The Synthes Cranial Plates are titanium plates in a variety of shapes The Synanes Crand for various cranio-facial procedures.

The Synthes Cranial Plates are intended for use in selective trauma of The ByInthos Craniofacial skeleton; craniofacial surgery; the initiface and craineral in is selective orthognathic surgery of the maxilla and chin

Titanium

Synthes(USA) Synthes Cranial Plates 510(k) CONFIDENTIAL

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2002

Mr. Matthew M. Hull Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K020087

Trade/Device Name: Synthes Cranial Plates Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Codes: JEY and GXR Dated: January 07, 2002 Received: January 10, 2002

Dear Mr. Hull:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Secuon 710(x) personalially equivalent (for the referenced above and have attermined to legally marketed predicate devices marketed in
indications for use stated in the enclosure , to legally marketed in
the enclose for us indications for use stated in the cholosator , to he enactment date of the Medical Device interstate commerce prior to reay 20, 1770, and enified in accordance with the provisions of
Amendments, or to devices that have been reclassified in accordance approvel of a Amendments, or to devices that nave been rocal require approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that do not requires, subject to the general the Federal Food, Drug, and Cosment / col (recore, market the device, subject to the general
approval application (PMA). You may, therefore, market the Act include approval application (1 MA). "Tou may) and controls provisions of the Act include controls provisions or the Act. The genting of devices, good manufacturing practice, requirements for annical rogginst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III) If your device is classified (sec above) incolors. Existing major regulations affecting
(PMA), it may be subject to such additional controls. Time 21, Rests 800 to 898 (PMA), it may be subject to Such additional concern Regulations, Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title Register i your device can be found in the Code of Pecelar regionerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualles of a substance of the requirements
mean that FDA has made a determination that your device complies with organizes mean that FDA has made a decemination untily of the Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies.

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## Page 2 - Mr. Matthew M. Hull

You must comply with all the Act's requirements, including, but not limited to: registration
ing and the many of the line (0) - GED Port Roll); good manufacturing practice You must comply with all the Act s'requirence.se increating oud manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 807); labellity (21 CF PC PC PC Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality systems (QB) regulation (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 allow you to begin marketing your covistantial equivalence of your device to
510(k) premarket notification. The FDA finding of sourcevice and thus, 510(k) premarket notification. The PDA finantig or casestion for your device and thus, a legally mur device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801
) and the If you desire specific advice for your device in vitro diagnostic devices), please contact the and additionally 21 CFR Part 809.10 for in valid the donestions on the promotion and
Office of Compliance at [phone]. Additionally, for questions on the promotion and Office of Compliance at [phone]. "Italifone of Compliance at [phone].
advertising of your device, please contact the Office has been programs to premarket advertising of your device, picase consisted, "Misbranding by reference to premarket. Also, please note the regulation entitled, "Internation on your responsibilities under
notification" (21CFR Part 807.97). Other general information on your responsibilities notification" (21CFR Part 807.97). Unier general Manufacturers, International and the Act may be obtained from the Division of Only 638-2041 or [phone] or at its
Consumer Assistance at its toll-free number (80) was an html Consumer Assistance at its ton nov fodrh/dsma/dsmamain.html

Sincerely yours,

Patrea Cinciniffe

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

Enclosure

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#### Indications for Use Statement 2.

## 510(k) Number (if known):

Device Name:

Indications for Use:

## Synthes Cranial Plates

The Synthes Cranial Plates are intended for use in I he Synthes Crainal I lawdface and craniofacial is selective trauma of the mirala"; reconstructive skeleton; cramoracial surgery, orthognathic surgery of the maxilla and chin.

020087

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

CONFIDENTIAL

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

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| Division Sign-Off | Phamida D. Sood for Swann H |
|-------------------|-----------------------------|
| | Dental Infection Control, |
| | ral Devices |
| | KC20087 |

#### Synthes(USA) Synthes Cranial Plates 510(k)