The DePuy Anatomic Locking Plating System is intended for fixation of fractures, fusions, osteotomies and non-unions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia and fibula, particularly in osteopenic bone.

Device Description

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

AI/ML Overview

This document is a 510(k) summary for the DePuy Anatomic Locking Plating System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria through a clinical study or a standalone algorithm performance study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device performance study is not applicable to this 510(k) summary.

The 510(k) summary states:

"The DePuy Anatomic Locking Plating System is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data." This indicates that equivalence was shown through non-clinical testing (e.g., mechanical tests, materials characterization), not a clinical study with performance metrics like sensitivity, specificity, or accuracy.
"No new issues of safety or efficacy have been raised." This reinforces that the submission aims to show the device is as safe and effective as existing, legally marketed devices, not to establish new safety or efficacy profiles to meet specific performance criteria.

In summary, the provided document does not contain the information requested because it is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a predicate device rather than meeting specific pre-defined acceptance criteria through a new performance study.

Summary

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Kor300

FEB 1 8 2009

SECTION 5 - 510(K) SUMMARY

Submitted by:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw. IN 46581 (305) 269-6386 Phone: (305) 269-6441 Fax:

Suzana Otaño, Project Manager, Regulatory Affairs Contact Person:

and accessories (21 CFR § 888.3030)

equivalent to currently marketed devices.

August 11, 2008 Date Prepared:

Anatomic Locking Plating System Proprietary Name:

Plate, Fixation, Bone Common Name:

Classification Name:

Predicate Devices:

Intended Use:

Single/multiple component metallic bone fixation appliances

The DePuy Anatomic Locking Plating System is substantially

Technological Characteristics:

Summary of Substantial Equivalence: The technological characteristics of the DePuy Anatomic Locking Plating System are similar to the predicate devices including design and material.

The DePuy Anatomic Locking 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.

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

Page 22 of 159

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings, with a human figure nestled within the wing area.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics Inc. % Ms. Suzana Otaño Manager, Regulatory Affairs P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581

Re: K082300

Trade/Device Name: Anatomic Locking 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, HWC, HTN Dated: January 30, 2009 Received: February 2, 2009

FEB 1 8 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. On to 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, TDA 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 af the Act or any Federal statutes and regulations administered by other Federal agencies. You numb 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 ss set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the sectionic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Suzana Otaño

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 Biometrics' (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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Mark A. Milliken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number:

K 08 2300

Device Name:

Anatomic Locking 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 (QDE)

Mark A. Millman

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

510(k) Number

Page 1 of 1

Anatomic Locking Plating System TradItional 510(k) DePuy Orthopaedics, Inc.

Page 21 of 159

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.