PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS

K090877 · DePuy Orthopaedics, Inc. · HRS · Jun 26, 2009 · Orthopedic

Device Facts

• Record ID: K090877
• Device Name: PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jun 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Proximal Tibia Plating System is intended for treatment of nonunions, osteotomies, malunions, osteopenic bone and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic and fractures with associated shaft fractures.

Device Story

Proximal Tibia Plating System consists of metallic bone plates and associated fixation hardware; used by orthopedic surgeons in clinical/OR settings for internal fixation of proximal tibia fractures and related bone conditions. Device provides mechanical stabilization of bone segments to facilitate healing. Surgeon selects appropriate plate configuration based on fracture pattern; hardware is implanted via standard orthopedic surgical techniques. Benefits include restoration of skeletal alignment and stabilization of bone fragments.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation plates and accessories. Design and materials are similar to existing predicate devices. Class II medical device (21 CFR 888.3030).

Indications for Use

Indicated for patients requiring surgical fixation of proximal tibia fractures, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, periprosthetic, and shaft-associated fractures, as well as nonunions, malunions, osteotomies, and osteopenic bone.

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.

Submission Summary (Full Text)

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K090877 (pg. 1 of 1)

# Section 5 — 510(k) Summary

| Submitted by: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581<br>Phone: [phone]<br>Fax: [phone] | JUN 26 2009 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Suzana Otaño, Project Manager, Regulatory Affairs | |
| Date Prepared: | March 30, 2009 | |
| Proprietary Name: | Proximal Tibia Plating System | |
| Common Name: | Plate, Fixation, Bone | |
| Classification<br>Name: | Single/multiple component metallic bone fixation appliances<br>and accessories (21 CFR § 888.3030) | |
| Predicate Devices: | The DePuy Proximal Tibia Plating System is substantially<br>equivalent to currently marketed devices. | |
| Intended Use: | The DePuy Proximal Tibia Plating System is intended for<br>treatment of nonunions, osteotomies, malunions, osteopenic<br>bone and fractures of the proximal tibia, including simple,<br>comminuted, lateral wedge, depression, medial wedge,<br>bicondylar combination of lateral wedge and depression,<br>periprosthetic and fractures with associated shaft fractures. | |
| Technological<br>Characteristics: | The technological characteristics of the DePuy Proximal Tibia<br>Plating System are similar to the predicate devices including<br>design and material. | |
| Summary of<br>Substantial<br>Equivalence: | The DePuy Proximal Tibia Plating System is substantially<br>equivalent to currently marketed devices as demonstrated with<br>pre-clinical data. No new issues of safety or efficacy have<br>been raised. | |

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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 and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

JUN 26 2009

9200 Corporate Boulevard

Food and Drug Administration

Public Health Service

Rockville MD 20850

DePuy Orthopaedics. Inc. % Ms. Suzana Otaño Project Manager 700 Orthopaedic Drive Warsaw, Indiana 46581

#### Re: K090877

Trade/Device Name: Proximal Tibia Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS, HWC Dated: March 30, 2009 Received: March 31, 2009

Dear Ms. Otaño:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Suzana Otaño

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely yours,

Barbara Buellm

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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# Section 4 - Indications for Use Statement

510(k) Number:

Device Name:

K090877

# Proximal Tibia Plating System

### Indications For Use:

The DePuy Proximal Tibia Plating System is intended for treatment of nonunions, osteotomies, malunions, osteopenic bone and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic and fractures with associated shaft fractures.

X Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*(Division Sign-Off)*

Division of Surgical, Orthopedia and Restorative Devices

510(k) Number K090872

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Proximal Tibia Plating System Traditional 510(k) DePuy Orthopaedics, Inc.

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