The DePuy Peak Fx Hip Plate System is comprised of plates in various lengths with two to twelve holes, barrely assemblies in various lengths with angles from 125° to 140°, a key and key screw, and a limited collapse caro.

AI/ML Overview

This 510(k) submission (K063509) for the DePuy Peak Fx Hip Plate directly states that the substantial equivalence is shown by its similarity in intended use, indications for use, materials, and design to the existing DePuy Captured Hip Screw System (CHS), K813554, cleared on January 12, 1982.

This means the submission is not based on performance testing of the device against specific acceptance criteria. Instead, it relies on the predicate device standard. Therefore, the document does not contain information about:

A table of acceptance criteria and reported device performance.
Sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, or how ground truth was established for this specific device.

The FDA's letter explicitly states: "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..."

In summary, the information requested in your prompt related to performance studies, acceptance criteria, and ground truth establishment is not present in the provided 510(k) summary as this device was cleared based on substantial equivalence to a predicate device, rather than new clinical performance data.

Summary

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K063509

510 (k) Summary

JAN - 4 2007

(As required by 21 CFR 807.92 and 21 CFR 807.93)

NAME OF SPONSOR:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46582Establishment Registration Number: 1818910
510(K) CONTACT:	Rhonda MyerRegulatory AffairsTelephone: (574) 371-4927Facsimile: (574) 371-4987Electronic Mail: Rmyer7@dpyus.jnj.com
DATE PREPARED:	November 6, 2006
PROPRIETARY NAME:	Peak Fx Hip Plate
COMMON NAME:	Bone Screw and Plate for Internal Fixation
CLASSIFICATION:	Class II device per 21 CFR 888.3030:Single/Multiple component metallic bone fixatioappliances and accessories
DEVICE PRODUCT CODE:	87 KTT
SUBSTANTIALLY EQUIVALENTDEVICES:	DePuy Captured Hip Screw System (CHS),K813554, cleared on January 12, 1982

DEVICE DESCRIPTION:

INTENDED USE AND INDICATIONS:

Intended Use: The DePuy Peak Fx Hip Plate is intended for internal fixation of hip fractures.

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Indications for Use:

The Peak Fx Hip Plate is indicated for the following fractures of the proximal femur:

. Basilar neck fractures
. Intertrochanteric fractures
. Subtrochanteric fractures

The Peak Fx Hip Plate is indicated for stable and unstable fractures in which a stable medial buttress can be reconstructed.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The substantial equivalence of the DePuy Peak Fx Hip Plate is shown by its similarity in intended use, indications for use, materials and design to the existing DePuy Captured Hip Screw System (CHS), K813554, cleared on January 12, 1982.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller, lighter font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Associate, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582

JAN 0 4 2007

Re: K063509

Trade/Device Name: Peak Fx Hip Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, HRS Dated: November 17, 2006 Received: November 20, 2006

Dear Ms. Myer:

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, Orug, 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 more 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 100-1000,

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Page 2 – Ms. Rhonda Myer

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 Office of Compliance at (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

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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Image /page/4/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo features a black circle to the left of the name "DePuy" in a stylized font. A horizontal line underlines the name, and below that, the text "a Johnson & Johnson company" is written in a smaller font. The logo is simple and professional, reflecting the company's corporate identity.

DePuy Orthopaedics, Inc.

PO Box 988 700 Orthopaedic Drive Warsaw, IN 46581-0988 USA Tel: +1 (574) 267 8143 Fax: +1 (574) 371 4987

Indications for Use Statement

510 (k) Number (if known):	K063509
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Device Name:

Indications for Use:

The Peak Fx Hip Plate is indicated for the following fractures of the proximal femur:

Basilar neck fractures .
Intertrochanteric fractures ●
. Subtrochanteric fractures

The Peak Fx Hip Plate is indicated for stable and unstable fractures in which a stable medial buttress can be reconstructed.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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 General, Restorative,
and Neurological Devices

54000 Number.

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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.