FEMORAL INTRAFIX SCREW AND SHEATH

K063577 · Johnson & Johnson Company · MBI · Jan 25, 2007 · Orthopedic

Device Facts

• Record ID: K063577
• Device Name: FEMORAL INTRAFIX SCREW AND SHEATH
• Applicant: Johnson & Johnson Company
• Product Code: MBI · Orthopedic
• Decision Date: Jan 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Femoral Intrafix Screw and Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

Device Story

Femoral Intrafix Screw and Sheath is a two-part non-absorbable implant system used in cruciate ligament reconstruction. The system comprises an expandable sheath and a screw. During surgery, the sheath is inserted into the bone tunnel to separate graft strands and position them against the tunnel wall; the screw is then inserted into the sheath to expand it, compressing the graft against the bone. The device is used by surgeons in an operating room setting. It provides mechanical fixation of soft tissue grafts to bone, facilitating ligament healing and stability. The system is used in conjunction with manual surgical instruments.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-absorbable, two-part metallic bone fixation fastener system consisting of an expandable sheath and a screw. Designed for soft tissue graft fixation in bone tunnels. Classified under 21 CFR 888.3040 (Product codes MBI and HWC).

Indications for Use

Indicated for fixation of soft tissue grafts during cruciate ligament reconstruction in patients requiring such surgical intervention.

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

• Intrafix Screw and Sheath (K983560)
• Milagro Interference Screw (K032717)
• Bio-Intrafix Screw and Sheath (K032167)

Submission Summary (Full Text)

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K063577

## SECTION 2 – 510(k) SUMMARY

## Femoral Intrafix Screw and Sheath

| | JAN 2 5 2007 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name and<br>Address: | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 |
| Contact Person | Ruth C. Forstadt<br>Project Management Lead, Regulatory Affairs<br>DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767<br>Telephone: [phone]<br>Facsimile: 508-828-3750<br>e-mail: [e-mail] |
| Name of Medical Device | Classification Name: Fastener, Fixation, Nondegradable, Soft<br>Tissue Smooth or threaded metallic bone<br>fixation fasteners |
| | Common/Usual Name: Orthopedic Screw, Fixation Device<br>Proprietary Name: Femoral Intrafix Screw and Sheath |
| Substantial Equivalence | The Femoral Intrafix Screw and Sheath is substantially equivalent to:<br>Intrafix Screw and Sheath (K983560); the Milagro Interference Screw<br>(K032717) and the Bio-Intrafix Screw and Sheath (K032167). |
| Device Classification | This device carries an FDA product code MBI and HWC, and is<br>classified as Fastener, Fixation, Nondegradable, Soft Tissue Smooth or<br>threaded metallic bone fixation fasteners under 21 CFR 888.3040. |
| Device Description | The Femoral Intrafix Screw and Sheath are non-absorbable implants<br>used to secure soft tissue grafts to the bone during cruciate ligament<br>reconstruction. The two-part system consists of an expandable sheath<br>that is inserted into the center of the tunnel. The sheath separates the<br>graft strands and places them against the tunnel wall. The screw is<br>inserted into the center of the expansion sheath. |

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sheath and compresses the tissue against the bone. This device system
consists of the following components:
Femoral Intrafix Screws and Sheaths in various sizes
*Various manual surgical instruments
* The various manual surgical instruments are Class I exempt (per 21
CFS 888.4540 "Orthopaedic Manual Surgical Instruments) stand-alone
instruments used as an aide during the surgical application.

| Indications for Use | Femoral Intrafix Screw and Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and Performance | Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices. Based on the indications for use, technological characteristics, and comparison to predicate devices, the Femoral Intrafix Screw and Sheath has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. |

:

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Mitek A Johnson & Johnson company % Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

JAN 2 5 2007

Re: K063577

Trade/Device Name: Femoral Intrafix Screw and Sheath Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI and HWC Dated: November 29, 2006 Received: November 30, 2006

Dear Ms. Forstadt:

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

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Page 2 – Ms. Ruth C. Forstadt

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 premated 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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): ____________________________________________________________________________________________________________________________________________________

Device Names: Femoral Intrafix Screw and Sheath

The Femoral Intrafix Screw and Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _______
(Division Sign-Off)
Division of General Restorative,
and Neurological Devices

| 510(k) Number | 1063577 |
|---------------|---------|
|---------------|---------|

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