LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM

K083843 · DePuy Orthopaedics, Inc. · HRS · Mar 20, 2009 · Orthopedic

Device Facts

• Record ID: K083843
• Device Name: LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Locking Anatomic & Composite Plating System is intended for fixation of fractures, osteotomies and non-unions of the fibula, malleolus, metatarsals and metacarpals, olecranon, clavicle, scapula, distal humerus and humeral head, radius, ulna and distal tibia, particularly in osteopenic bone.

Device Story

Locking Anatomic & Composite Plating System consists of metallic bone plates and accessories for orthopedic fixation. Device provides mechanical stabilization of fractures, osteotomies, and non-unions in various anatomical sites, including long bones and extremities. Designed for use in osteopenic bone where traditional fixation may be compromised. Operated by orthopedic surgeons in clinical or surgical settings. Device functions as a mechanical implant to maintain bone alignment during healing process; provides structural support to bone segments. Benefits include improved fixation stability in compromised bone tissue.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation system; single/multiple component plates and accessories. Design and materials are similar to predicate devices. Class II device under 21 CFR 888.3030.

Indications for Use

Indicated for patients requiring fixation of fractures, osteotomies, and non-unions of the fibula, malleolus, metatarsals, metacarpals, olecranon, clavicle, scapula, distal humerus, humeral head, radius, ulna, and distal tibia, with specific utility in 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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K083843

### MAR 2 0 2009

# SECTION 5 - 510(K) SUMMARY

Submitted by: DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw. IN 46581 Phone: [phone] Fax: [phone] Contact Person: Suzana Otaño, Project Manager, Regulatory Affairs December 23, 2008 Date Prepared: Proprietary Name: Locking Anatomic & Composite Plating System Common Name: Plate, Fixation, Bone Classification Single/multiple component metallic bone fixation appliances Name: and accessories (21 CFR § 888.3030) Predicate Devices: The DePuy Locking Anatomic & Composite Plating System is substantially equivalent to currently marketed devices. Intended Use: The DePuy Locking Anatomic & Composite Plating System is intended for fixation of fractures, osteotomies and non-unions of the fibula, malleolus, metatarsals and metacarpals, olecranon, clavicle, scapula, distal humerus and humeral head, radius, ulna and distal tibia, particularly in osteopenic bone. Technological The technological characteristics of the DePuy Locking Characteristics: Anatomic & Composite Plating System are similar to the predicate devices including design and material. Summary of The DePuy Locking Anatomic & Composite Plating System is Substantial substantially equivalent to currently marketed devices as Equivalence: demonstrated with pre-clinical data. No new issues of safety or efficacy have been raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAR 2 0 2009

DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Dr. Warsaw, Indiana 46581-0988

Re: K083843

Trade/Device Name: Locking Anatomic & Composite 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 23, 2008 Received: December 24, 2008

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 includions 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 Amendmonts, 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, isting 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. Suzana Otaño

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 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 the reporting 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,

Ar. Airm.D. fo

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

K083843 510(k) Number:

#### Locking Anatomic & Composite Device Name: Plating System

### Indications For Use:

The DePuy Locking Anatomic & Composite Plating System is intended for fixation of fractures, osteotomies and non-unions of the fibula, malleolus, metatarsals and metacarpals, olecranon, clavicle, scapula, distal humerus and humeral head, radius, ulna and distal tibia, particularly in osteopenic bone.

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)

tonsion (Division of General, Restorative, and Neurological Devices

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510(k) Number

Locking Anatomic & Composite Plating System Traditional 510(k) DePuy Orthopaedics, Inc.

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