4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.

K072423 · DePuy Orthopaedics, Inc. · HRS · Nov 7, 2007 · Orthopedic

Device Facts

• Record ID: K072423
• Device Name: 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Nov 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Large Fragment Locking Plating System is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation and stabilization of non-unions, malunions and osteotomies.

Device Story

Large Fragment Locking Plating System consists of metallic bone plates and screws; used for internal fixation of long bone fractures (humerus, femur, tibia), osteopenic bone, and stabilization of non-unions, malunions, and osteotomies. Device implanted by orthopedic surgeons in clinical/surgical settings. Provides mechanical stabilization to facilitate bone healing. System design and materials are equivalent to existing predicate locking plating systems.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material comparison to predicate devices.

Technological Characteristics

Metallic bone fixation plates and screws. Design and materials are identical to predicate devices. Class II device (21 CFR 888.3030).

Indications for Use

Indicated for fixation of long bones (humerus, femur, tibia), osteopenic bone, and stabilization of non-unions, malunions, and osteotomies in patients requiring orthopedic bone fixation.

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 Large Fragment Dynamic Compression Locking System (K000682)
• DePuy POLYAX™ Locked Plating System (K060969)

Submission Summary (Full Text)

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# Section 5 — 510(k) Summary

| Submitted by: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581<br>Phone: [phone]<br>Fax: [phone] | | | | | NOV 07 2007 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------------------|--|--|-------------|
| Contact Person: | Suzana Otaño, Sr. Regulatory Affairs Associate | | | | | |
| Date Prepared: | August 28, 2007 | | | | | |
| Proprietary Name: | Large Fragment Locking 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: | Synthes | K000682 | Large Fragment Dynamic<br>Compression Locking<br>System | | | |
| | DePuy | K060969 | POLYAX™ Locked Plating<br>System | | | |
| Intended Use: | The Large Fragment Locking Plating System is intended for<br>fixation of various long bones, such as the humerus, femur and<br>tibia. It is also for use in fixation of osteopenic bone and<br>fixation and stabilization of non-unions, malunions and<br>osteotomies. | | | | | |
| Technological<br>Characteristics: | The technological characteristics of the Large Fragment<br>Locking Plating System are the same as the predicate devices<br>including design and material. | | | | | |
| Summary of<br>Substantial<br>Equivalence: | The Large Fragment Locking Plating System is substantially<br>equivalent to the currently marketed Synthes and DePuy<br>devices. No new issues of safety or efficacy have been raised. | | | | | |

ﺒﺔ

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol.

#### Public Health Service

NOV 0 7 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Suzana Otano Sr. Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46581

K072423 Re:

Trade/Device Name: Large Fragment Locking Plating System Regulation Number: 21 CFR 888.3030 Regulation Name; Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: October 8. 2007 Received: October 9, 2007

Dear Otano:

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 -- Suzana Otano

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Oalvarezm

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

K072423 510(k) Number:

### Large Fragment Locking Plating Device Name: System

Indications For Use: The Large Fragment Locking Plating System is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation and stabilization of non-unions, malunions and osteotomies.

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)

Sarbaro buen

Division of General, Restorative. and Neur Jogical Devices

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**510(k) Number** K072423

Large Fragment Locking Plating System Traditional 510(k) DePuy Orthopaedics, Inc.