MODIFICATION TO: LIGAFIX INTERFERENCE SCREW

K070507 · Science For Biomaterials · HWC · Mar 29, 2007 · Orthopedic

Device Facts

• Record ID: K070507
• Device Name: MODIFICATION TO: LIGAFIX INTERFERENCE SCREW
• Applicant: Science For Biomaterials
• Product Code: HWC · Orthopedic
• Decision Date: Mar 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LigaFix® interference screws are designed for the interference fixation of grafts in anterior cruclate ligament reconstruction.

Device Story

LIGAFIX® are resorbable cannulated bone fixation screws used in anterior cruciate ligament (ACL) reconstruction. The device provides mechanical interference fixation of grafts within the bone. The screws are composed of a composite of ceramic (β-TCP) and polymer (Poly Lactic Acid). The product line includes two material specifications (30% TCP/70% PLA and 60% TCP/40% PLA), three head designs (standard, reduced, rounded), and various diameters (7-11 mm) and lengths (20-35 mm). The device is supplied sterile for use by surgeons in clinical settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological similarities to previously cleared predicate devices.

Technological Characteristics

Resorbable cannulated bone fixation screw. Materials: Composite of ceramic (β-TCP) and polymer (Poly Lactic Acid). Two formulations: 30% TCP/70% PLA and 60% TCP/40% PLA. Dimensions: 7-11 mm diameter, 20-35 mm length. Head designs: standard, reduced, rounded. Sterilization: Supplied sterile in double heat-sealed pouches.

Indications for Use

Indicated for interference fixation of grafts in anterior cruciate ligament reconstruction.

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)
• LIGAFIX® Resorbable Interference Screw (K061262)

Submission Summary (Full Text)

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

Ko7o5o7

SPECIAL 510k

LIGAFIX® Interference screws

Image /page/0/Picture/3 description: The image shows the words "Science for Bio Materials" in a stylized font. The word "Science" is in a smaller font than the words "Bio Materials". There are three right-pointing triangles to the right of the words. The words "Science for Bio Materials" are underlined.

#### MAR 2 9 2007 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

#### 1. GENERAL INFORMATION

| 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<br>devices | LIGAFIX® Resorbable Interference Screw K050407 and K061262 |
| 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-mall : [e-mail] |

#### 2. DEVICE DESCRIPTION

LIGAFIX® are resorbable cannulated screws made of ceramic (β-ΤCP) / polymer (Poly Lactic Acid) composite and designed for the interference fixation of grafts in anterlor cruciate ligament reconstruction.

To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of LIGAFIX Interference screws comprise:

- 2 material specifications: LIGAFIX® 30 (30% TCP/70% PLA) and LIGAFIX® 60 (60% o TCP/40% PLA)
- 3 head design: standard reduced -- rounded ಂ
- Diameters from 7 mm to 11 mm 0
- Lengths from 20 mm to 35 mm ం

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# SPECIAL 510k

LIGAFIX® Interference screws

SCIENCE FOR BIO MATERIALS

LIGAFIX® interference screws are supplied sterile and individually packaged In double heat sealed pouches.

## 3. INTENDED USE

"LigaFix® interference screws are designed for the interference fixation of grafts in anterior cruclate ligament reconstruction."

## 4. SUBSTANTIAL EQUIVALENCE

The additional LIGAFIX® Interference screws have the same fundamental scientific technology, operating principle and intended use as previously cleared LIGAFIX® Interference screw K050407 and K061262.

Summary preparation date: February 13, 2007

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2007

Science For Biomaterials % Mr. Denis Clement General Manager ZI du Monge F 65100 LOURDES, FRANCE

Re: K070507

> 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: February 16, 2007 Received: February 27, 2007

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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Denis Clement

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" (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/cdrb/industry/support/index.html.

Sincerely yours,

Harbare Buellio

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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SPECIAL 510k LIGAFIX® Interference screws

SCIENCE FOR BIO MATERIALS

# Indications for Use

510(k) Number (if known):

K070507

Device Name: LIGAFIX® RESORBABLE INTERFERENCE SCREW

Indications for Use;

"LigaFix® interference screws are 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)

Aubare bucher

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

510(k) Number K07507

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