ACE NANCY NAIL

K032687 · DePuy Orthopaedics, Inc. · HTY · Oct 6, 2003 · Orthopedic

Device Facts

• Record ID: K032687
• Device Name: ACE NANCY NAIL
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Oct 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The 450 mm Nancy Nail™ is intended as a temporary implant to aid in the healing of long bone (tibia, humerus, femur, etc.) fractures at diaphyseal, metaphyseal and epiphyseal levels. It is intended for use in children above four years of age and in any patient below 65 kg. The 100 mm Nancy Nail™ is designed to treat fractures of small long bones with long diaphyses such as carpal or tarsal bones. The 450 mm Nancy Nail™ is also intended for use in upper extremity fractures in all patients.

Device Story

Titanium alloy intramedullary elastic nail; temporary fixation device for long bone fractures. Implanted surgically to provide mechanical stability during bone healing; removed after healing. Available in 450 mm length (multiple diameters) for long bones and 100 mm length for small long bones. Used by orthopedic surgeons in clinical settings. Provides internal splinting to facilitate fracture union; benefits patient by stabilizing bone segments to promote healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarities to legally marketed predicate devices.

Technological Characteristics

Titanium alloy intramedullary pin. Available in 450 mm (2.0, 2.5, 3.0, 3.5, 4.0 mm diameters) and 100 mm (1.0 mm diameter) lengths. Single-use, temporary implant. Mechanical fixation device.

Indications for Use

Indicated for children >4 years old and patients <65 kg for long bone fractures (tibia, humerus, femur) at diaphyseal, metaphyseal, and epiphyseal levels; also indicated for small long bone fractures (carpal, tarsal) and upper extremity fractures in all patients.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• DePuy ACE® Nancy Nail™ (K960642)
• Synthes Elastic Intramedullary Nail System (K971783)

Submission Summary (Full Text)

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510(k): ACE® Nancy Nail™ K032687

510(k) Summary 10-6-03

# 510(k) Summary

| Name of Sponsor: | DePuy ACE®, Inc.<br>700 Orthopaedic Drive<br>Warsaw, Indiana 46581-0988<br>Est. Reg. No.1818910 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Rhonda Myer<br>Regulatory Affairs<br>Phone: [phone]<br>FAX: [phone] |
| Trade Name: | ACE® Nancy Nail™ |
| Common Name: | Intramedullary Elastic Nail |
| Classification: | Class II Device per 21 CFR 888.3040:<br>Smooth or threaded metallic bone fixation fastener |
| Device Product Code: | 87 HTY |
| Substantially Equivalent<br>Devices: | DePuy ACE® Nancy Nail™ K960642<br>Synthes Elastic Intramedullary Nail System K971783 |
| Device Description: | The Nancy Nail™ is a titanium alloy pin that is implanted<br>to facilitate the fixation of long bone fractures. The Nancy<br>Nail™ is available in two lengths; the 450 mm is available<br>in five diameters (2.0, 2.5, 3.0, 3.5, 4.0 mm), and the 100<br>mm is available in 1.0 mm diameter. The Nancy Nail™ is<br>a single-use device intended for temporary implantation. It<br>is intended to be removed once the bone has healed. |

న్ని మొత్తమైన సామానికి చెందిన గ్రామం నుండి 10 కి.మీ. దూర

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### 510(k) Summary (continued)

Indications for use:

The 450 mm Nancy Nail™ is intended as a temporary implant to aid in the healing of long bone (tibia, humerus, femur, etc.) fractures at diaphyseal, metaphyseal and epiphyseal levels. It is intended for use in children above four years of age and in any patient below 65 kg. The 100 mm Nancy Nail™ is designed to treat fractures of small long bones with long diaphyses such as carpal or tarsal bones. The 450 mm Nancy Nail™ is also intended for use in upper extremity fractures in all patients.

This submission covers the additional indication for use in upper extremity fractures in all patients.

This indication has been cleared previously for the Synthes Elastic Intramedullary Nail System, K971783. . . .

#### Substantial equivalence:

Based on similarities of design, materials, and indications for
use, DePuy believes the ACE® Nancy Nail™ is substantially equivalent to the Synthes Elastic Intramedullary Nail System, K971783.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

OCT - 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rhonda Myer Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw. Indiana 46581-0988

Re: K032687

Trade/Device Name: ACE® Nancy Nail™ Regulation Number: 21 CFR 3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: August 28, 2003 Received: August 29, 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 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 not 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 proctice 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 CPR 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 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.

Mark N. Melker

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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**510(k) Number:** K060654

510(k) Number: K032687

## Device Name: ACE® Nancy Nail TM

### Indications for Use:

The 450 mm Nancy Nail™ is intended as a temporary implant to aid in the healing of long bone (tibia, humerus, femur, etc.) fractures at diaphyseal, metaphyseal and epiphyseal levels. It is intended for use in children above four years of sge and in any patient below 65 kg. The 100 mm Nancy Nail™ is designed to treat fractures of small long bones with long diaphyses such as carpal or tarsal bones. The 450 mm Nancy Nail™ is also intended for use in upper extremity fractures in all patients.

Concurrence of CDRH, Office of Device Evaluation

for Mark A. Millicus

Division Sign-Off) Dision of General, Re rative and Neurological Devic

(k) Number K032687

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Prescription Use ાર Over-The-Counter Use (Per 21 CFR 801.109)