MEMORY STAPLE (20 SIZES AVAILABLE)

K964226 · Landos, Inc. · JDR · Aug 5, 1997 · Orthopedic

Device Facts

• Record ID: K964226
• Device Name: MEMORY STAPLE (20 SIZES AVAILABLE)
• Applicant: Landos, Inc.
• Product Code: JDR · Orthopedic
• Decision Date: Aug 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Memory Staple is intended for bone fixation for the indications of osteotomies and arthrodeses of the mid-foot bones, the metatarsals, the phalanges, and associated joints of the foot.

Device Story

Memory Staple is a single-use, bicortical compression bone fixation appliance. Manufactured from shape memory Nickel-Titanium alloy. Implanted permanently to provide compression across osteotomy or arthrodesis sites in foot surgery. Utilizes shape memory properties to maintain fixation. Used by surgeons in clinical settings. Benefits include stable bone fixation for mid-foot, metatarsal, and phalangeal procedures.

Clinical Evidence

Clinical evidence includes a reported study by Barouk (1994) documenting successful use of the device in 315 osteotomies of the great toe between 1991-1994. Bench testing performed to compare prong separation strength against the Landos Standard Staple.

Technological Characteristics

Bicortical compression staple; material: Nickel-Titanium shape memory alloy; single-use; permanent implant.

Indications for Use

Indicated for bone fixation in patients undergoing osteotomies or arthrodeses of the mid-foot, metatarsals, phalanges, and associated foot joints.

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

• Landos Standard Staple
• Stryker Osteoclasp
• Mitek Anchor II

Submission Summary (Full Text)

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07/30/97 WED 12:50 FAX [phone]
DePuy Clinical & Regulat
003
K964226
AUG - 5 1997

# SUMMARY OF SAFETY AND EFFECTIVENESS

## MANUFACTURER IDENTIFICATION:
Medinov-AMP
27 à 31 rue Lucien Langenieux
42335 Roanne FRANCE

## ESTABLISHMENT REGISTRATION NUMBER (Manufacturer):
9681744

## SPONSOR IDENTIFICATION:
Cheryl Hastings
DePuy, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46580

## ESTABLISHMENT REGISTRATION NUMBER (Sponsor):
1818910

## PROPRIETARY NAME:
Memory Staple™

## PRODUCT CLASSIFICATION CODE:
87JDR

## PROPOSED REGULATORY CLASS:
Class II

## DESCRIPTION:
The Memory Staple is a single use bone fixation appliance intended to be permanently implanted. It is a bicortical compression staple made of a shape memory Nickel-Titanium alloy.

## INTENDED USE AND INDICATIONS:
The Memory Staple is intended for bone fixation for the indications of osteotomies and arthrodeses of the mid-foot bones, the metatarsals, the phalanges, and associated joints of the foot.

## PREDICATE DEVICES:
The Memory Staple is substantially equivalent to:
1) The Landos Standard Staple
2) The Stryker Osteoclasp
3) The Mitek Anchor II™

## BASIS OF SUBSTANTIAL EQUIVALENCE:
The Memory Staple, the Landos Standard Staple and the Stryker Osteoclasp are all intended for bone fixation. The Memory Staple and the Mitek Anchor II are both manufactured from Nickel-Titanium shape memory alloy.

## SUMMARY OF STUDIES:
Prong separation tests were performed on the Memory Staple and the Landos Standard Staple. The results showed that the Memory Staple had more than twice the strength of the Landos Standard Staple. Successful clinical use of the Memory Staple in 315 osteotomies of the great toe between 1991-1994 was reported by Barouk in 1994.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Ms. Cheryl Hastings
Manager Clinical Affairs
DePuy, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988

Re: K964226
Trade Name: Memory Staple
Regulatory Class: II
Product Code: JDR
Dated: May 30, 1997
Received: June 2, 1997

Dear Ms. Hastings:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

AUG - 5 1997

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Page 2 - Ms. Cheryl Hastings

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Page 1 of 1
CONFIDENTIAL

510(k) Number (if known) K964226

Device Name: Memory Staple™

Indications For Use:
For Fixing the osteotomies and arthrodesis of the midfoot bones, the metatarsals, the phalanges, and associated joints of the foot.

(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 Devices
510(k) Number K964226

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)

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