STRYKER FOOT PLATING SYSTEM

K063875 · Howmedica Osteonics Corp. · HRS · Mar 15, 2007 · Orthopedic

Device Facts

• Record ID: K063875
• Device Name: STRYKER FOOT PLATING SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker® Foot Plating System is intended for use in internal fixation, reconstruction or arthrodeses of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

Device Story

Stryker Foot Plating System is a line extension of bone fixation hardware; includes locking plates, bone screws, and locking screws. Used for internal fixation, reconstruction, or arthrodesis of small bones in foot and ankle. Operated by surgeons in clinical/OR settings. Provides mechanical stabilization of bone segments to facilitate healing via rigid fixation. Benefits include structural support for bone fusion and fracture repair.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation system consisting of plates and screws. Materials and design principles are consistent with existing legally marketed bone fixation appliances (21 CFR 888.3030).

Indications for Use

Indicated for internal fixation, reconstruction, or arthrodesis of small bones in the fore, mid-, and hind foot and ankle, including replantation, lag screw techniques, joint fusions, corrective osteotomies, and fracture treatment.

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

• Profyle® System
• Stryker® Plating System
• DARCO Locking Bone Plate System (Darco International, Inc.)
• Synthes LCP Locking Calcaneal Plates and Modular Foot System

Submission Summary (Full Text)

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K063875

# 510(k) Summary of Safety and Effectiveness Stryker® Foot System

MAR 1 5 2007

| Proprietary Name: | Stryker® Foot Plating System |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone plates and screws |
| Classification Name/Reference: | Single/multiple component metallic bone fixation<br>appliances and accessories, 21 CFR §888.3030 |
| Device Product Code: | 87 HRS |
| Proposed Regulatory Class: | Class II |
| For Information contact: | Vivian Kelly, Senior Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone] Fax: [phone] |
| Date Summary Prepared: | December 28, 2006 |

## Description

This submission is a line extension to the Stryker® Plating System to add alternate styles of plates and screws including locking plates, bone screws and locking screws for use in the foot and ankle.

#### Indications:

The Stryker® Foot Plating System is intended for use in internal fixation, reconstruction or arthrodeses of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

#### Substantial Equivalence:

The subject Stryker® Foot Plating System is substantially equivalent to other plating systems in regards to intended use, design, materials, and operational principles as internal fixation components such as the Profyle® System, Stryker® Plating System, DARCO Locking Bone Plate System, Darco International, Inc. and Synthes LCP Locking Calcaneal Plates and Modular Foot System.

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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 features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Howmedica Osteonics Corp % Ms. Vivian Kelly Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430

MAR 1 5 2007

Re: K063875

Trade/Device Name: Stryker Foot Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: December 28, 2006 Received: December 29, 2006

Dear Ms. Kelly:

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 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.

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## Page 2 - Ms. Vivian Kelly

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,

Charbare MuenD

Mark N. Melkerson 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

510(k) Number (if known):

Device Name: Stryker® Foot Plating System

Indications for Use:

The Stryker® Foot Plating System is intended for use in internal fixation, reconstruction or arthrodeses of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Joubare BuemP

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

**510(k) Number** K063875

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