(87 days)
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).
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.
This document does not contain the information required to populate the requested table and study details regarding acceptance criteria and device performance. The provided text is a 510(k) summary for the Biomet Intex Screw, which outlines the device's name, classification, indications for use, device description, and potential risks, as well as the FDA's clearance letter. It does not include details about acceptance criteria, specific performance metrics, or any studies demonstrating the device meets such criteria.
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance study details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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NOV 1 6 2001
Kd2798
page 1 of 1
SUMMARY OF SAFETY AND EFFECTIVENESS
- Biomet, Inc. Sponsor: P.O. Box 587 Warsaw, IN 46581-0587
Contact Person: Dalene T. Binkley (800) 348-9500, 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
Page l of (
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
00004
N/A