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 Description

The DePuy Locking Anatomic & Composite Plating System is substantially equivalent to currently marketed devices.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device called the "DePuy Locking Anatomic & Composite Plating System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding:

Acceptance criteria and reported device performance (in a table format).
Sample sizes used for test sets, data provenance, and ground truth establishment details for a study proving acceptance criteria.
Number of experts, their qualifications, and adjudication methods for establishing ground truth.
Results of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
Ground truth type, training set sample size, and ground truth establishment for a training set.

The document is a regulatory approval notice based on the substantial equivalence of the new device to existing predicate devices, primarily demonstrated through pre-clinical data, not clinical performance studies against specific acceptance criteria.

Key information present in the document:

Device Name: Locking Anatomic & Composite Plating System
Intended Use: For fixation of fractures, osteotomies, and non-unions of various bones (fibula, malleolus, metatarsals, metacarpals, olecranon, clavicle, scapula, distal humerus and humeral head, radius, ulna, and distal tibia), especially in osteopenic bone.
Summary of Substantial Equivalence: "The DePuy Locking Anatomic & Composite Plating System is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data. No new issues of safety or efficacy have been raised."

This type of 510(k) submission relies on demonstrating that the new device has "technological characteristics... similar to the predicate devices including design and material" and that pre-clinical data supports its equivalence, rather than setting and meeting specific performance acceptance criteria in a clinical study.

Summary

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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: (305) 269-6386 Fax: (305) 269-6441 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

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, a symbol often associated with medicine and healthcare, with three overlapping lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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:

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.

Page 18 of 112

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.