INTEX SCREW

K012798 · Biomet, Inc. · HWC · Nov 16, 2001 · Orthopedic

Device Facts

• Record ID: K012798
• Device Name: INTEX SCREW
• Applicant: Biomet, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Intex Screw is indicated for fixation of bone fractures and for bone reconstruction (i.e. fresh fractures, osteotomy, revision procedure where other treatments or devices have failed, arthrodesis, and in conjunction with fixation hardware).

Device Story

Intex Screw is an internal fixation device for skeletal fracture alignment and stabilization. Device comprises an internal cannulated screw joined to an external stud. During treatment, external stud connects to an external fixator to maintain stabilization. Upon healing, external stud is removed, leaving internal cannulated screw in situ for continued internal fixation. Used by surgeons in clinical settings. Benefits include transition from external to internal fixation without secondary surgery to remove the entire construct.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Internal cannulated screw with external stud junction. Metallic bone fixation fastener. Class II device. Product code HWC.

Indications for Use

Indicated for fixation of bone fractures and bone reconstruction in patients requiring fresh fracture repair, osteotomy, revision procedures, arthrodesis, or adjunctive fixation.

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.

Submission Summary (Full Text)

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NOV 1 6 2001

Kd2798
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## SUMMARY OF SAFETY AND EFFECTIVENESS

- Biomet, Inc. Sponsor: P.O. Box 587 Warsaw, IN 46581-0587
Contact Person: Dalene T. Binkley [phone], ext. 1612

Device Name: Intex Screw

Classification Name: screw, fixation, bone fastener (21 CFR 888.3040)

Device Product Code: 87 HWC

Indications for Use: The Intex Screw is to be for fixation of bone fractures and for bone reconstruction (i.e. fresh fractures, osteotomy, revision procedure where other treatments or devices have failed, arthrodesis, and in conjunction with fixation hardware).

Device Description: The Intex Screw is an internal fixation device intended to aid in the alignment and stabilization of fractures in the skeletal system until healing has occurred.

The Intex Screw consists of an internal cannulated screw and an external stud joined at a junction. After inserting the device, the external stud is held in place by an external fixator to allow for healing. When the surgeon feels that external fixation is no longer needed, the external stud is removed, leaving the internal cannulated screw. This design allows the surgeon to maintain internal fixation after the external fixation device is removed.

Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:

Reaction to bone cement Deformity of the joint Cardiovascular disease Fracture of the cement Implant loosening/migration Tissue growth failure

Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Nerve damage

Bone fracture Infection Hematoma Dislocation Excessive wear

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2001

Ms. Dalene T. Binkley Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581

Re: K012798

Trade/Device Name: Intex™ Screw Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: August 20, 2001 Received: August 21, 2001

Dear Ms. Binkley:

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 I ou may , aroney annovisions 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 or any 1 vith 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 - Ms. Dalene T. Binkley

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.

Sincerely, your,

for Mark N. Miller

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

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NOV 1 6 2001

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## 510 (k) NUMBER (IF KNOWN): _ | L | 2 7 9 8

DEVICE NAME: Intex™ Screw

INDICATIONS FOR USE:

The Intex Screw is indicated for fixation of bone fractures and for bone reconstruction (i.e. fresh fractures, osteotomy, revision procedure where other treatments or devices have failed, arthrodesis, and in conjunction with fixation hardware).

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter-Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K 012798

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