MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10

K070033 · Memometal Technologies · JDR · Mar 19, 2007 · Orthopedic

Device Facts

• Record ID: K070033
• Device Name: MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10
• Applicant: Memometal Technologies
• Product Code: JDR · Orthopedic
• Decision Date: Mar 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEMOMETAL varisation staple is intended to be implanted for fixation of small bone fractures or for small bone reconstruction.

Device Story

MEMOMETAL varisation staple is a metallic bone fixation device featuring two self-drilling tips. Designed for use in orthopedic procedures, specifically Akin type osteotomies, to correct valgus deformation of the first ray and reconstruct foot anatomy. The device is implanted by a surgeon to provide fixation for small bone fractures or reconstruction. It functions as a mechanical stabilizer for bone segments. Two staple configurations are available to accommodate different bone surface geometries.

Clinical Evidence

Bench testing only. The device conforms to ASTM F564-02 (Standard Specification and Test Methods for Metallic Bone Staples) and ISO 5832-1 (Wrought stainless steel for surgical implants).

Technological Characteristics

Metallic bone staple; material: wrought stainless steel (ISO 5832-1); design: two self-drilling tips; standard compliance: ASTM F564-02.

Indications for Use

Indicated for Akin type osteotomies.

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 Inc varisation staple

Submission Summary (Full Text)

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K070033

## SECTION 5: 510(K) SUMMARY

MAR 1 9 2007

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

As required by section 807.92(c)

| Submitter | MEMOMETAL TECHNOLOGIES |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Campus de Ker Lann - Rue Blaise Pascal |
| | 35170 BRUZ - France |
| | Phone : + 33 (0)2 99 05 50 66 |
| | Fax :+ 33 (0)2 99 05 95 62 |
| Contacts | Gilles AUDIC Quality Manager |
| | Bernard PRANDI General Manager |
| | e-mail: [e-mail] |
| Preparation date | December 15, 2006 |
| Trade Name | MEMOMETAL varisation staples (AV XX-YY) |
| Common Name | Varisation staples |
| Classification Name | Staples, Fixation, Bone |
| Legally marketed<br>predicate devices | (DEPUY Inc) varisation staple |
| Description | MEMOMETAL varisation staple is a staple with two self<br>drilling tips. The treatment with a varisation staple allows, after<br>possible treatment of the second ray, to correct the valgus<br>deformation of the first ray and to recreate a square or Greek<br>foot. Two types of staples are available depending on the<br>bone surface |
| Intended Use | The MEMOMETAL varisation staple is intended to be<br>implanted for fixation of small bone fractures or for small bone<br>reconstruction. |
| Indication for use | The MEMOMETAL varisation staple is indicated for Akin<br>type osteotomy. |
| Performance data | The MEMOMETAL varisation staple is conform to ASTM<br>F564-02 Standard Specification and Test Methods for Metallic<br>Bone staples and to ISO 5832-1 Implants for surgery -<br>Metallic materials - Part 1: Wrought stainless steel (ISO 5832- |

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| 510k Premarket Notification | |
|------------------------------|--|
| Varisation staples MEMOMETAL | |
| TECHNOLOGIES | |

| | 1:1997). |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial equivalence | THE MEMOMETAL varisation staples are substantially equivalent to their predicate devices Depuy .inc varisation staples in terms of intended use and indications for use, material, design and function. Any minor differences between these two devices do not raise new questions of safety and effectiveness. |

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, with three flowing lines forming the body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Memometal Technologies % Gilles Audic Quality Manager Rue Blaise Pascal Campus De Kerr Lann Bruz, France F35170

MAR 1 9 2007

Re: K070033

Trade/Device Name: Memometal Varization Staples Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: December 19, 2006 Received: January 03, 2007

Dear Mr. Audic:

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

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## Page 2 - Mr. Gilles Audic

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. 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,

Barbere Buchup

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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## INDICATIONS FOR USE

510(k) Number (if known): Device Name: MEMOMETAL VARISATION Indications for Use:

- The MEMOMETAL varisation staples (AV XX-YY) are indicated for Akin type osteotomies
Prescription Use >| AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Buehlm

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

**510(k) Number** K070033