SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM

K031725 · Synthes (Usa) · KTT · Jun 24, 2003 · Orthopedic

Device Facts

• Record ID: K031725
• Device Name: SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: Jun 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Ti-15Mo Locking Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

Device Story

System consists of machined metallic plates and screws; provides screw-to-plate locking mechanism. Used for fixation of complex intra- and extra-articular fractures and osteotomies of distal radius and other small bones. Operated by surgeons in clinical/OR settings. Provides mechanical stabilization of bone fragments to facilitate healing.

Technological Characteristics

Materials: Titanium-15% molybdenum alloy. Components: Machined metallic plates and screws. Feature: Screw-to-plate locking mechanism. Intended for orthopedic fixation.

Indications for Use

Indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes Distal Radius Plate System

Submission Summary (Full Text)

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JUN 2 4 2003

K031725
page 1 of 1

## 3. 510(k) Summary

| Sponsor | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Bonnie Smith |
| Name of the Device | Synthes Ti-15Mo Locking Distal Radius Plating System |
| Device Classification(s) | Class II, §888.3030 - Plate, Fixation, Bone<br>Class II, §888.3040 - Screw, Fixation, Bone |
| Predicate Device | Synthes Distal Radius Plate System |
| Device Description | The Synthes Ti-15Mo Locking Distal Radius Plating System<br>consists of machined metallic plates and screws that offer<br>screw to plate locking designed for various fracture modes of<br>the distal end of the radius. |
| Indications | The Synthes Ti-15Mo Locking Distal Radius Plating System<br>is intended for fixation of complex intra- and extra-articular<br>fractures and osteotomies of the distal radius and other small<br>bones. |
| Materials | Titanium-15% molybdenum |
| Substantial Equivalence | Documentation is provided which demonstrates that the<br>Synthes Ti-15Mo Locking Distal Radius Plating System is<br>substantially equivalent* to other legally marketed Synthes<br>devices. |
| | * The term "substantial equivalence" as used in this 510(k)<br>notification is limited to the definition of substantial<br>equivalence found in the Food, Drug and Cosmetic Act, as<br>amended and as applied under 21 CFR 807, Subpart E, under<br>which a device can be marketed without pre-market approval<br>or reclassification. A determination of substantial<br>equivalency under this notification is not intended to have any<br>bearing whatsoever on the resolution of patent infringement<br>suits or any other patent matters. No statements related to, or<br>in support of substantial equivalence herein shall be construed<br>as an admission against interest under the US Patent Laws or<br>their application by the courts. |

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three horizontal lines above a wavy line, which is the department's symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 4 2003

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. PA 19301

Re: K031725

Trade/Device Name: Synthes Ti-15Mo Locking Distal Radius Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: June 2, 2003 Received: June 3, 2003

Dear Ms. Smith:

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. 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

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Page 2 - Ms. Bonnie J. Smith

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,

Mark A. Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological 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:

3172)5

Synthes Ti-15Mo Locking Distal Radius Plating System_

The Synthes Ti-15Mo Locking Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use

Alhals A. Miller

Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K03

10004