The Ortho-Pro Cannulated Bone Screw consists of a threaded implant and corresponding instrumentation to facilitate insertion. The implants are cylindrical in shape and incorporate a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal hex-head allows for maximum torque with minimal risk of stripping. These screws are of the self-tapping type. This device is manufactured from Ti-6A1-4V alloy and is available in a variety of sizes.

AI/ML Overview

This 510(k) summary describes a bone screw, which is a physical medical device, not an AI/ML enabled device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device based on material, indications for use, and similar thread form, which are criteria relevant to physical orthopedic implants.

Summary

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Ortho-Pro Cannulated Bone Screw 510(k) Summary August 21, 2004

SEP 1 6 2004

16 042310

Submitter	Ortho-Pro LLCSuite 3033450 Highland Dr.Salt Lake City, UT 84106
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J.D. Webb Contact person 1001 Oakwood Blvd Round Rock. TX 78681 512-388-0199
Trade Name Cannulated Bone Screws

Bone screw Common name

Class II per 21 CFR section 888.3040 Classification name

Product Code HWC
Equivalent Device Vilex Cannulated Screws (K991151).

Device Description

Intended Use

The Ortho-Pro Cannulated Bone Screws are indicated for bone fractures, osteotomies, artrhodeses, osteochronditis and tendon reattachment.

These screws are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Summary of Technological Characteristics Compared to Predicate Device

The Ortho-Pro Cannulated Bone Screws are made from the same material, have the same indications and have similar thread form as compared to the predicate device.

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Image /page/1/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2004

Ortho-Pro LLC C/o Mr. J.D. Webb OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K042310

Trade/Device Name: Ortho-Pro Cannulated Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: August 21, 2004 Received: August 25, 2004

Dear Mr. Webb:

We have reviewed your Section 510(k) premarket notification of intent to market the device we neve roview your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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 may be dayse to back and 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has Intactions 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 rord in radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and my Jan finding of substantial equivalence of your device to a legally prematic notification "caresults 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 If you active of Compliance at (301) 594-4659. 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 other general 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 yours,

Miriam C. Provost

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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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Ortho-Pro Cannulated Bone Screws are indicated for bone fractures, osteotomies, artrhodeses, osteochronditis and tendon reattachment.

These screws are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Rest rative. and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.