LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60

K050407 · Sciences For Bio Materials · HWC · Nov 4, 2005 · Orthopedic

Device Facts

• Record ID: K050407
• Device Name: LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60
• Applicant: Sciences For Bio Materials
• Product Code: HWC · Orthopedic
• Decision Date: Nov 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

LIGAFIX® is a resorbable cannulated bone screw used in anterior cruciate ligament (ACL) reconstruction. Device composed of 30% beta-tricalcium phosphate (β-TCP) and 70% poly-lactic acid (PLA) composite. Features triangular socket for screwdriver interface to improve torque distribution. Used by orthopedic surgeons in clinical settings to provide interference fixation of grafts during ACL repair. Sterile, single-use device. Provides sustained graft fixation during healing process; material resorbs over time.

Clinical Evidence

Bench testing only. Biological, mechanical, and biocompatibility tests performed. Results confirmed high biocompatibility and mechanical strength retention profiles compatible with the healing process.

Technological Characteristics

Cannulated interference screw; material: 30% β-TCP / 70% PLA composite; triangular socket interface; sterile; single-use.

Indications for Use

Indicated for patients undergoing anterior cruciate ligament (ACL) reconstruction requiring interference fixation of grafts.

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

• BioLok® Screw (K002070)
• BIOSORB® Resorbable Void Filler (K021963)

Submission Summary (Full Text)

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### 510(k) Premarket Notification K050407 LIGAFIX® Interference screw

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## 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 devices | BioLok® Screw K002070 (Biocomposites Ltd)<br>BIOSORB® Resorbable Void Filler K021963 (SBM) |
| 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] |

# NOV - 4 2005

#### 2. DEVICE DESCRIPTION

LIGAFIX® is a resorbable cannulated screw designed for the interference fixation of grafts in anterior cruciate ligament reconstruction. LIGAFIX® interference bone screw is made of a 30% ceramic (ß-TCP) / 70% polymer (Poly Lactic Acid -PLA)(6v composite. LIGAFIX® interference bone screws are supplied sterile and individually packaged in double heat sealed pouches. LIGAFIX® screws present a socket which accepts a screwdriver of triangular cross-section that inserts deep into the core of the screw, to produce improved torque distribution.

#### 3. INTENDED USE

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

#### 4. PERFORMANCE DATA

Biological, mechanical and biocompatibility tests have been performed. Results confirmed that LIGAFIX® screws are highly biocompatible and presents the requisite strength to provide sustained fixation of the graft. LIGAFIX® screws strength retention profiles are compatible with the healing process.

## 5. SUBSTANTIAL EQUIVALENCE

LIGAFIX® is substantially equivalent to its predicate device BioLok® in terms of intended use, material, design and function.

Revised version: October 13, 2005

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

NOV - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Denis Clement General Manager Sciences et BioMatériaux ZI du Monge F 65100 Lourdes FRANCE

Re: K050407

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: October 17, 2005 Received: October 24, 2005

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

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Page 2 - Mr. Denis Clement

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. 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 may be obtained 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,

Mark N. Melkerson

der Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K050407

Device Name: LIGAFIX® RESORBABLE INTERFERENCE SCREW

#### Indications for Use:

LIGAFIX® is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (β-ΤCP) and Poly Lactic Acid (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)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------------------------|-----------|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | 0 0 0 0 4 |
| 510(k) Number | K050407 |
| Page 1 of 1 | |