MEMOMETAL FIXOS SCREWS

K070039 · Memometal Technologies · HWC · Mar 21, 2007 · Orthopedic

Device Facts

• Record ID: K070039
• Device Name: MEMOMETAL FIXOS SCREWS
• Applicant: Memometal Technologies
• Product Code: HWC · Orthopedic
• Decision Date: Mar 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-FIX) are indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.

Device Story

MEMOMETAL FIXOS Screws are single-use, cannulated compressive or snap-off bone fixation appliances; permanently implanted to stabilize elective osteotomies of mid-foot, metatarsal, and phalangeal bones. Used by surgeons in clinical settings. Device provides mechanical fixation to facilitate bone healing.

Clinical Evidence

Bench testing only. Device conforms to ASTM F543-02 (Metallic Bone screw) and ISO 5832-3 (Wrought titanium 6-aluminium 4-vanadium alloy).

Technological Characteristics

Cannulated compressive and snap-off bone screws. Material: Titanium alloy (Ti-6Al-4V ELI). Standards: ASTM F543-02, ISO 5832-3.

Indications for Use

Indicated for fixation and stabilization of elective osteotomies of mid-foot bones, metatarsals, and phalanges of the foot.

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

• LANDOS twist-off screw (K962233)
• LANDOS Scarf thread-head screw (K962236)

Submission Summary (Full Text)

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510k Premarket Notification FIXOS SCREWS MEMOMETAL TECHNOLOGIES

K070039

(1622)

## SECTION 5: 510(K) SUMMARY

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

MAR 2 1 2007

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 59 69 |
| | Fax :+ 33 (0)2 99 05 95 62 |
| Contacts | Gilles AUDIC Quality Manager |
| | Bernard PRANDI General Manager |
| | e-mail: [e-mail] |
| | [e-mail] |
| Preparation date | December 19, 2006 |
| Trade Name | MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-Fix) |
| Common Name | FIXOS Screws |
| Classification Name | Screw, Fixation, Bone |
| Legally marketed | K962233 LANDOS twist-off screw (LANDOS acquired by |
| predicate devices | DEPUY Inc). |
| | K962236 LANDOS Scarf thread-head screw (LANDOS |
| | acquired by DEPUY Inc) |
| Description | MEMOMETAL FIXOS SCREWS are single-use bone fixation |
| | appliances intended to be permanently implanted. Screws are |
| | cannulated compressive screws made of titanium alloy (Ti - |
| | 6Al -4V ELI) and snap-off screws made of titanium alloy (alloy |
| | (Ti - 6Al -4V ELI) |

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510k Premarket Notification FIXOS SCREWS MEMOMETAL TECHNOLOGIES

# KOF 0039 (2 g 2)

| Intended Use &<br>Indication for use | The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-<br>FIX) are indicated for fixing and stabilizing the elective<br>osteotomies of the mid-foot bones and the metatarsal and<br>phalanges of the foot only. |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data | The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-<br>FIX) conform to ASTM F543-02 Standard Specification and<br>Test Methods for Metallic Bone screw (Section A1, A2 and<br>A3) and to ISO 5832-3 Implants for surgery - Metallic<br>materials - Part 3: Wrought titanium 6-aluminium 4-vanadium<br>alloy. |
| Substantial equivalence | THE MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-<br>FIX) are substantially equivalent to their predicate devices<br>LANDOS CANNULATED BONE SCREW and TWIST-OFF<br>SCREW in terms of intended use and indications for use,<br>material, design and function. Any minor differences between<br>these two devices do not raise new questions of safety and<br>effectiveness. |

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1. The state of the state

Page 12

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

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

MAR 2 1 2007

Re: K070039

Trade/Device Name: Memometal Fixos Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 28, 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 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 - Mr. Gilles Audic

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 vours.

Barbara Bouchard

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

K020039 510(k) Number (if known): Device Name: MEMOMETAL FIXOS® SCREWS Indications for Use:

- The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-Fix) are indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
Prescription Use > (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)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Soubare Brelup
(Division Sign-Off)

Division of General, Restorative, and New of General, Resto
and Neurological Devices

510(k) **Number** K070039