BIO-EUROLIG INTERFERENCE SCREW

K031939 · Fournitures Hospitalieres Industrie · HWC · Jun 24, 2004 · Orthopedic

Device Facts

• Record ID: K031939
• Device Name: BIO-EUROLIG INTERFERENCE SCREW
• Applicant: Fournitures Hospitalieres Industrie
• Product Code: HWC · Orthopedic
• Decision Date: Jun 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bio-Eurolig® screw is intended to provide interference fixations of bone-tendon-bone and soft tissue grafts in ACL reconstruction through arthroscopy or arthrotomy.

Device Story

Bio-Eurolig® screw is a bioabsorbable interference screw used for graft fixation in ACL reconstruction. Device is manufactured from Poly-Lactid Acid (PLA). Available in diameters of 7, 8, and 9mm and lengths of 25 and 30mm. Delivered sterile for single-use. Used by surgeons during arthroscopic or arthrotomic procedures to secure bone-tendon-bone or soft tissue grafts. Provides mechanical interference fixation to stabilize the graft during the healing process.

Clinical Evidence

Bench testing only. No clinical data provided. Functionality, durability, and safety were characterized through bench testing and compliance with manufacturing quality standards.

Technological Characteristics

Material: Poly-Lactid Acid (PLA). Form factor: Interference screw available in 7, 8, 9mm diameters and 25, 30mm lengths. Energy source: None (mechanical). Sterilization: Sterile. Connectivity: None.

Indications for Use

Indicated for interference fixation of bone-tendon-bone and soft tissue grafts during ACL reconstruction via arthroscopy or arthrotomy.

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

• BIO RCI (K992396)
• BIO Screw (K973758)
• ARTHREX Bio-Interference Screw (K971358)

Submission Summary (Full Text)

{0}------------------------------------------------

## JUN 2, 4, 2004

K031939 Page 122

## 510 (K) SUMMARY – BIO-EUROLIG® SCREW

| Submitter name: | Fournitures Hospitalières Industrie |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter adress: | 6 Rue Nobel, Z.I. de Kernevez<br>QUIMPER, France 29000 |
| Contact person: | C.QUENDEZ |
| Phone Number: | 33.2.98.55.68.95 |
| Fax Number: | 33.2.98.53.42.13 |
| Date prepared: | May 28, 2003 |
| Device Trade Name: | BIO-EUROLIG® SCREW |
| Device common name: | Bioabsorbable Interference Screw |
| Classification name: | Bone Fixation Screw |
| Predicate Devices: | BIO RCI<br>Smith & Nephew<br>K 992396 |
| | BIO Screw<br>Linvatec<br>K 973758 |
| | ARTHREX Bio-Interference Screw<br>Arthrex<br>K 971358 |
| Device description: | The Bio-Eurolig® screw is a bioabsorbable interference screw made of<br>Poly-Lactid Acid (PLA) and available in 3 diameters (7, 8 and 9mm)<br>and in 2 lengths (25 and 30). They are delivered sterile and are single<br>use. |
| Intended use: | The Bio-Eurolig® screw is intended to provide interference fixations of<br>bone-tendon-bone and soft tissue grafts in ACL reconstruction through<br>arthroscopy or arthrotomy. |

{1}------------------------------------------------

| Performance Data: | Risk to health have been addressed through the specified materials,<br>Processing controls, quality assurance and compliance to the Medical<br>Device Good Manufacturing Practices Regulations. Testing were<br>performed to characterize the functionality, durability and safety of the<br>Bio-Eurolig® screws. |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The Bio-Eurolig® Screws are substantially equivalent to predicate<br>devices in terms of intended use, safety, and effectiveness. |

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2004

Mr. M. Philippe Schweblin President du Directoire Fournitures Hospitaliéres Industrie ZI de Kernevez – 6 rue Nobel 29000 Quimper France

Re: K031939 Trade/Device Name: Bio-Eurolig® Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 25, 2004 Received: March 29, 2004

Dear Mr. Schweblin:

We have reviewed your Section 510(k) premarket notification of intent to market the indicati we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced above and have actoring active marketed predicate devices marketed in interstate for use stated in the enclosure) to regard actual date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food. Drug, devices mat nave tech recuire approval of a premarket approval application (PMA). and Cosmetic Act (7101) that do not required to the general controls provisions of the Act. The 1 ou may, therefore, market of the Act include requirements for annual registration, listing of general controls provisions of mactice, 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 If your device is classified (500 a0070) ins tExisting major regulations affecting your device can a may be subject to such additional combines, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Dri 3 issualles complies with other requirements of the Act that I DA has made a active and regulations administered by other Federal agencies. You must of any I cochar statutes und regulations, including, but not limited to: registration and listing (21 Comply with an the Her 800 manufacturing practice requirements as set CI K Fart 607); adoning (2) (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality of course (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

## Page 2 – Mr. M. Philippe Schweblin

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow yourse overnment of substantial equivalence of your device to a legally premarket notineation: "The 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 If you desire specific acriver 181 ) 394-4639. Also, please note the regulation entitled, Collider the Office of Come to premarket notification" (21CFR Part 807.97) you may obtain. IMISoranding by reference to premiesponsibilities under the Act may be obtained from the Oincl general information on your 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,

Sincerely yours,

Mark N. Adkison

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

{4}------------------------------------------------

510 K Number (if known):

K031939

BIO-EUROLIG® screw

Device Name:

Indications For Use:

The BIO-EUROLIG® screw is intended to provide interference fixations of bone-tendonbone and soft tissue grafts in ACL reconstruction through arthroscopy or arthrotomy.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH | Office of Device Evaluation |
|---------------------|-----------------------------|
|---------------------|-----------------------------|

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

| 510(k) Number | K031939 |
|---------------------------------------|---------|
| Prescription Use (Per 21 CFR 801.109) | Yes |
| Over-The-Counter Use | No |

(Optional Format 1-2-96)