MEMORY STAPLE

K060746 · DePuy Orthopaedics, Inc. · JDR · May 25, 2006 · Orthopedic

Device Facts

• Record ID: K060746
• Device Name: MEMORY STAPLE
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: JDR · Orthopedic
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Memory Staple is intended to be implanted for bone fixation in the foot. Memory 12 and Memory 20 staples are implants intended for fixation of the foot. Memory 12 staples are indicated for osteotomies of the first phalanx of the foot. Memory 20 staples are indicated for arthrodesis of the first metatarsal phalangeal joint. The patient's anatomy and skeleton must be capable of receiving the selected implant.

Device Story

Memory Staple is a single-use, bicortical compression bone fixation appliance implanted in the foot. Manufactured from Nickel-Titanium alloy; provides mechanical fixation for osteotomies or arthrodesis. Used by surgeons in clinical settings. Device provides structural stability to bone segments to facilitate healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bicortical compression staple; material: Nickel-Titanium alloy; single-use; mechanical fixation device.

Indications for Use

Indicated for patients requiring bone fixation in the foot, specifically osteotomies of the first phalanx (Memory 12) or arthrodesis of the first metatarsal phalangeal joint (Memory 20). Requires patient anatomy/skeleton capable of receiving the implant.

Regulatory Classification

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.

Predicate Devices

• DePuy Memory Staple (Size 12) (K964226)

Submission Summary (Full Text)

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K0607 46

## 510 (k) Summary

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

MAY 2 5 2006

| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.<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] |

DATE PREPARED:

February 23, 2006

Memory™ Staple

Facsimile: [phone]

Electronic Mail: [e-mail]

PROPRIETARY NAME:

COMMON NAME:

CLASSIFICATION:

DEVICE PRODUCT CODE:

SUBSTANTIALLY EQUIVALENT DEVICES:

Bone Fixation Staple

Class II device per 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener 87 JDR

DePuy Memory Staple (Size 12), K964226, cleared on August 5, 1997

# DEVICE DESCRIPTION:

The Memory Staple is a single-use, bone fixation appliance intended to be implanted in the foot. It is a bicortical compression staple manufactured from a Nickel-Titanium alloy.

## INTENDED USE AND INDICATIONS:

# Intended Use:

The Memory Staple is intended to be implanted for bone fixation in the foot.

### Indications for Use:

Memory 12 staples are indicated for osteotomies of the first phalanx of the foot. Memory 20 staples are indicated for arthrodesis of the first metatarsal phalangeal joint.

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## BASIS OF SUBSTANTIAL EQUIVALENCE:

The substantial equivalence of the DePuy Memory Staple is substantiated by its similarity in intended use, indications for use, materials and design to the existing DePly Memory Staple, cleared in K964226, on August 5, 1997.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

#### Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2006

DePuy Orthopaedics, Inc % Ms. Rhonda Myer Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K060746

Trade/Device Name: Memory™ Staple Regulation Number: CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDR Dated: March 17, 2006 Received: March 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, 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 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 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/industry/support/index.html.

Sincerely yours,

Herbert Lehman

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 solid black circle to the left of the name "DePuy" in a bold, sans-serif font. Below the name is the text "a Johnson-Johnson company" in a smaller, cursive font.

DePuy Orthopaedics, Inc.

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

Tel: [phone]

### Indications for Use Statement

1000746

510 (k) Number (if known):

Device Name:

Indications for Use:

Memory 12 and Memory 20 staples are implants intended for fixation of the foot.

Memory 12 staples are indicated for osteotomies of the first phalanx of the foot. Memory 20 staples are indicated for arthrodesis of the first metatarsal phalangeal joint.

The patient's anatomy and skeleton must be capable of receiving the selected implant.

Concurrence of CDRH, Office of Device Evaluation (ODE)

X

Prescription Use:

Over-The-Counter-Use: OR

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

Herbert Penner

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

510(k) Num