ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM

K033878 · Depuy Ace · HSB · Feb 20, 2004 · Orthopedic

Device Facts

• Record ID: K033878
• Device Name: ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM
• Applicant: Depuy Ace
• Product Code: HSB · Orthopedic
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACE® A/R Humeral Nail is a single use device intended for fixation of humeral fractures.

Device Story

Intramedullary nail system for fixation of humeral fractures; includes nail, cancellous/cortical screws, and end caps. Nail features anterior/posterior and lateral/medial screw holes, distal/proximal bends, and distal locking screw post for antegrade or retrograde insertion. Used by surgeons in clinical settings to stabilize fractures. Provides mechanical fixation to facilitate bone healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Intramedullary nail system; diameters 7, 8, 9mm; lengths 200-300mm. Includes cancellous and cortical screws and end caps. Mechanical fixation device.

Indications for Use

Indicated for open and closed fracture patterns, humeral shaft fractures, proximal and distal metaphysis fractures, comminuted fractures with small medullary canals, fracture non-unions and mal-unions, pathological fractures, and floating elbow.

Regulatory Classification

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.

Predicate Devices

• DePuy ACE® AIM Humeral Nail (K934643)
• Howmedica Osteonics Corp T2™ Humeral Nail System (K011529)

Submission Summary (Full Text)

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FEB 2 0 2004

033878
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## 510 (k) Summary

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

| NAME OF SPONSOR: | DePuy ACE®<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Establishment Registration Number: 1818910 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rhonda Myer<br>Regulatory Affairs<br>Telephone: [phone]<br>Facsimile: [phone]<br>Electronic Mail: [e-mail] |
| DATE PREPARED: | December 12, 2003 |
| PROPRIETARY NAME: | ACE® Antegrade Retrograde Humeral Nail System |
| COMMON NAME: | Intramedullary Nail |
| CLASSIFICATION: | Class II Device per 21 CFR 888.3020:<br>Intramedullary Fixation Rod |
| DEVICE PRODUCT CODE: | 87 HSB |
| SUBSTANTIALLY EQUIVALENT DEVICES: | DePuy ACE® AIM Humeral Nail, K934643<br>Howmedica Ostconics Corp T2™ Humeral Nail<br>System, K011529 |

## DEVICE DESCRIPTION:

The ACE® Antegrade Retrograde (A/R) Humeral Nail System includes an intramedullary nail, cancellous and cortical screws, and end caps and is intended for the firsting of humeral fractures. The nail is available in diameters of 7, 8, and 9 millimaters and lengths of 200-300mm, in 20mm increments. The nail incorporates anterior/posterior and lateral/medial screw holes, distal and proximal bends, a distal locking screw postcho may be inserted antegrade as well as retrograde.

## INTENDED USE AND INDICATIONS:

#### Intended Use:

The ACE® A/R Humeral Nail is a single use device intended for fixation of humeral fractures.

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033878
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#### Indications for Use:

The ACE® A/R Humeral Nail is indicated for open and closed fracture patterns, humeral shaft fractures, fractures of the proximal and distal metaphysis, comminuted fractures of the humerus with small medullary canals, fracture non-unions and mal-unions, pathological fractures, floating elbow.

### BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on the same intended use, indications for use, design features, materials, and sterilization processes, DePuy ACE® believes that the subject Antegrade Rotrograde Humeral Nail System is substantially equivalent to the previously cleared DePuy ACE® AIM Humeral Nail System (K934643) and the Howmedica Osteonics Corp T2™ Humeral Nail System (K011529).

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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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

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

Re: K033878

Trade/Device Name: DePuy ACE® Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 12, 2003 Received: December 15, 2003

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, 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, 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 may or saily of 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 I'DA's issuance of a substantial equivalence determination docs 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 or any I citial battler and securitements, 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 prested 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,
Mark A. McMullen

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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#### DePuy ACE

PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 USA Tel: [phone] Fax: [phone]

# Indications for Use Statement

510 (k) Number (if known): k033878

# Device Name: DePuy ACE® Antegrade Retrograde Humeral Nail System

Indications for Use:

The ACE® Antegrade Retrograde Humeral Nail System is indicated for open and closed fracture patterns, humeral shaft fractures, fractures of the proximal and distal metaphysis, comminuted fractures of the humerus with small medullary canals, fracture non-unions and mal-unions, pathological fractures, floating elbow.

Mark N. Millman

Division of General, Restorative, and Neurological Devices

510(k) Number K033878

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Over-The-Counter-Use: ાર