The ACE® Proximal Humeral Nail System is indicated for fixation of proximal humeral fractures. These implants are intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.

Device Description

The ACE® Proximal Humeral Nail System consists of an intramedullary nail, a slecve, and an end cap and is intended for the fixation of proximal three part humeral fractures. The short, straight nail is available in diameters of 8 and 10 millimeters and length of 150mm. It is designed to be inserted antegrade, in line with the intramedullary canal. The sleeve has been designed to lock all proximal screws to prevent backing out.

AI/ML Overview

This document is a 510(k) Summary for the DePuy ACE® Proximal Humeral Nail System. It describes the device, its intended use, indications for use, and establishes substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria.

Medical device 510(k) submissions, especially for devices like this intramedullary fixation rod, often demonstrate substantial equivalence through comparisons to predicate devices in areas like:

Intended Use: The purpose for which the device is used.
Indications for Use: The specific conditions or diseases the device is indicated to treat.
Technology: The fundamental scientific technology used by the device.
Materials: The materials from which the device is constructed.
Design: The physical characteristics and configuration of the device.
Performance: Mechanical and/or biological performance (e.g., sterilization, biocompatibility, mechanical strength).

The provided text explicitly states that "The substantial equivalence of the ACE® Proximal Humeral Nail is substantiated by its similarity in intended use, indications for use, materials and design to the Acumed Polarus (K951740) and the Fournitures Hospitaliéres Industrie Telegraph® Humcral Nail (K023241)."

Therefore, based solely on the provided text, I cannot complete the requested information regarding acceptance criteria and a study proving the device meets them. This type of information is not typically presented in the 510(k) Summary itself for this class of device, but would be found in the full 510(k) submission, which might include design verification and validation testing reports (e.g., mechanical testing, biocompatibility testing) comparing the new device to the predicate.

In summary, the provided document does not contain the information required to answer your request about acceptance criteria and a study demonstrating device performance against those criteria.

Summary

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FEB 2 0 2004

K033806
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510 (k) Summary

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

NAME OF SPONSOR:	DePuy ACE®700 Orthopaedic DriveWarsaw, Indiana 46581-0988Establishment Registration Number: 1818910
510(K) CONTACT:	Rhonda MyerRegulatory AffairsTelephone: (574) 371-4944Facsimile: (574) 371-4987Electronic Mail: Rmyer@dpyus.jnj.com)
DATE PREPARED:	November 21, 2003
PROPRIETARY NAME:	ACE® Proximal Humeral Nail System
COMMON NAME:	Intramedullary Fixation Rod
CLASSIFICATION:	Class II Device per 21 CFR 888.3020:Intramedullary Fixation Rod
DEVICE PRODUCT CODE:	87 HSB
SUBSTANTIALLY EQUIVALENTDEVICE:	Acumed Polarus, K951740Fournitures Hospitaliéres Industrie Telegraph®Humeral Nail, K023241

DEVICE DESCRIPTION:

INTENDED USE AND INDICATIONS:

Intended Use:

The ACE® Proximal Humcral Nail is a single use device intended for fixation of proximal humeral fractures.

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K033806
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Indications for Use:

BASIS OF SUBSTANTIAL EQUIVALENCE:

The substantial equivalence of the ACE® Proximal Humeral Nail is substantiated by its similarity in intended use, indications for use, materials and design to the Acumed Polarus (K951740) and the Fournitures Hospitaliéres Industrie Telegraph® Humcral Nail (K023241).

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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

FEB 2 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rhonda Myer Regulatory Affairs DePuy Ace 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K033806

Trade/Device Name: ACE® Proximal Humeral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 1, 2003 Received: December 8, 2003

Dear Ms. Myer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused in added is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to Commerce prof to May 20, 1978, in ecordance with the provisions of the Federal Food, Drug, de necs that have been recuire approval of a premarket approval application (PMA). and Cosmeter For (110) that to nevies, subject to the general controls provisions of the Act. The r ou may, mereror, mains 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 If your device is onastined (600 a00 rols. Existing major regulations affecting your device can may or sabject to back as a saceral 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 r rease of actived a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 - 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 If you desire specific advisoriance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Mulkern

Celia M. Witten, Ph.D., M.D. 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 ACE, a Johnson & Johnson company. The logo consists of a black circle followed by the word "DePuy" in bold, sans-serif font. To the right of "DePuy" is the word "ACE" in a similar font, but slightly smaller in size. Underneath the logo is the text "Johnson & Johnson company" in a smaller, serif font.

Johnson-Johnson compa

DePuy ACE

PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 USA

Indications for Use Statement

Tel: +1 (574) 267 8143 Fax: +1 (574) 267 7098

510 (k) Number (if known):

Device Name: k0380a

Indications for Use:

The ACE® Proximal Humeral Nail System is intended for the fixation of proximal humeral fractures.

These implants are intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.

Mark A. Mulkern

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

K033806

510(k) Number

(Please do not write below this line - continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Usc: ___

Over-The-Counter-Use: ()[ર

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.