LIGAFIX INTERFERENCE SCREW

K061262 · Sciences For Bio Materials · HWC · Jul 5, 2006 · Orthopedic

Device Facts

• Record ID: K061262
• Device Name: LIGAFIX INTERFERENCE SCREW
• Applicant: Sciences For Bio Materials
• Product Code: HWC · Orthopedic
• Decision Date: Jul 5, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LIGAFIX 30® interference screws are indicated for use in anterior cruciate ligament reconstruction to provide interference fixation of grafts.

Device Story

LIGAFIX 30° is a cannulated, resorbable interference bone screw used in anterior cruciate ligament (ACL) reconstruction. The device provides mechanical interference fixation of grafts within the bone. It is intended for use by surgeons in an operating room setting. The screw is composed of a composite material (30% beta-tricalcium phosphate and 70% Poly Lactic Acid). It is supplied sterile for single use. The device functions as a mechanical fastener to secure the graft during the healing process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cannulated interference screw. Materials: composite of 30% beta-tricalcium phosphate (ß-TCP) and 70% Poly Lactic Acid (PLA). Supplied sterile in double heat-sealed pouches. Mechanical fixation device.

Indications for Use

Indicated for use in anterior cruciate ligament (ACL) reconstruction to provide interference fixation of grafts. For prescription use only.

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

• LIGAFIX® Resorbable Interference Screw (K050407)

Submission Summary (Full Text)

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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Kob1262 page 172

5 2006

| Trade Name | LIGAFIX® Resorbable Interference Screw |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Bone Fixation Screw |
| Classification Name | Screw, Fixation, Bone |
| Class | II |
| Product Code | HWC |
| CFR section | 21CFR 888.3040 |
| Device panel | Orthopedic |
| Legally marketed predicate devices | LIGAFIX® Resorbable Interference Screw K050407 |
| Reason for special 510k | Extension of the range of products |
| Submitter | SCIENCE FOR BIOMATERIALS<br>Sciences et Bio Matériaux<br>ZI du Monge<br>F 65100 LOURDES - FRANCE<br>Owner operation Number : 9063735 |
| Contact | Denis CLEMENT, General Manager<br>Tel : [phone]<br>Fax : [phone]<br>e-mail : [e-mail]<br>Regulatory contact: Idée Consulting (FRANCE)<br>Isabelle DRUBAIX e-mail : [e-mail] |

#### 1. GENERAL INFORMATION

## 2. DEVICE DESCRIPTION

LIGAFIX 30° resorbable cannulated screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

LIGAFIX 30® interference screws are made of a ceramic (30% ß-TCP) / polymer (70% Poly Lactic Acid -PLA) composite.

LIGAFIX 30° interference screws are supplied sterile and individually packaged in double heat sealed pouches.

#### 3. INTENDED USE

LIGAFIX 30® interference screws are indicated for use in anterior cruciate ligament reconstruction to provide interference fixation of grafts.

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# 4. SUBSTANTIAL EQUIVALENCE

The modifications to LIGAFIX® Interference screw K050407 consist of additional size of screw together with the addition of a slightly modified design of the head of the screw.

The additional LIGAFIX® Interference screws have the same fundamental scientific technology, operating principle and intended use as previously cleared LIGAFIX® Interference screw K050407.

Summary preparation date: April 21, 2006

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1,061262

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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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A."

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Science For Bio Materials % Mr. Denis Clement General Manager ZI du Monge F 65100 Lourdes FRANCE

JUL - 5 2006

Re: K061262

Trade/Device Name: LIGAFIX® RESORBABLE INTERFERENCE SCREW Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 26, 2006 Received: June 28, 2006

Dear Mr. Clement:

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 clectronic 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 Scction 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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# Page 2 – Mr. Denis Clement

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" (21 CFR 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buchud

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): _ Kob1262

Device Name: LIGAFIX® RESORBABLE INTERFERENCE SCREW

### Indications for Use:

LIGAFIX 30 is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (30% β-TCP) and Poly Lactic Acid (70% PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

Prescription Use __ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use No
(21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative, and Neurological Devices

510(k) Numbe