CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)

{0}------------------------------------------------ SEP 2 2 2003 # 510(K) SUMMARY (as required by 807.92(c)) 032169 page 1 of 3 | Submitter of 510(k): | Cyber Orthology, Inc.<br>6301 Hughes Dr.<br>Sterling Heights, MI 48312<br><br>Phone: 586-264-9544<br>Fax: 586-264-9566 | | |------------------------------|------------------------------------------------------------------------------------------------------------------------|---------| | Contact Person: | Dr. Djoldas Kuldjanov | | | Date of Summary: | June 30, 2003 | | | Trade Name: | CyberOrthology Carbon Fiber Composite Circular Fixation<br>(CIRfix) Device (Half Ring) | | | Classification Name: | APPLIANCE, FIXATION, NAIL/BLADE/PLATE<br>COMBINATION, MULTIPLE COMPONENT | | | Classification Product Code: | KTT | | | Predicate Device: | Ilizarov External Fixation System | K962808 | | | External Fixation System | K870961 | | Intended Use: | | | Open and closed fracture fixation, nonunion, precise control of bone segments location including angulation, rotation, translation, lengthening, and shortening. The External Fixator also aids correction of bone deformities or defects associated with fractures and other pathological conditions of bone. The limb function is preserved if the External Fixator is properly applied. ### Conclusion: This device has equivalent intended use, has similar promotional claims, conforms to similar standards, and has equivalent technological characteristics to predicate devices. {1}------------------------------------------------ # Device Comparison Chart Image /page/1/Picture/1 description: The image shows handwritten text on a white background. The text at the top reads "K032169", and the text below reads "page 2 of 3". The handwriting is in black ink and appears to be cursive. | Comparison Items | CyberOrthology Carbon<br>Fiber Composite Circular<br>Fixation (CIRfix) device | Ilizarov External Fixation<br>System K962808 | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | Part of external fixator aiding<br>trophism in the correction of<br>bone deformities/defects. | Same | | Target population | Human of any gender and at<br>the advanced walking age | Same | | Design | Same physical design, except<br>aesthetically and tactual more<br>pleasing with improved<br>impression of superior<br>strength and safe mobility | Circular half-ring with<br>overlapping ends to form a<br>perfect ring when<br>joined together by bolts and<br>nuts | | Material | Radiolucent Carbon Fiber<br>Composite utilizing<br>Randomly orientated, pre-<br>impregnated carbon<br>strands resulting in a<br>carbon fiber content of<br>better than 62%. | Radiolucent Carbon Fiber<br>Composite featuring<br>pre-determined fiber<br>orientations and typically 55%<br>carbon fiber content. | | Performance | Comparatively tested,<br>indicating 15%-20%<br>superiority. | Compression Stiffness,<br>(ASTM F-1746). 3-Point<br>Bending. Cantilever Bending.<br>Wire Pull-out Test. | | Sterility | Shipped none-sterile & device<br>may be sterilized as required<br>by any method. | Same | | Biocompatibility | The component is a none<br>invasive external device and<br>will not be used for<br>implantation or contact with<br>skin or soft tissues. | Same | | Mechanical Safety | The test procedure<br>&requirements allow for the<br>appropriate amount of rigidity<br>and stability. | Same | | Chemical Safety | The device is indicated for use<br>in clinical and common patient<br>living environment not being<br>exposed to<br>harmful chemical elements | Same | | Compatibility with other<br>Devices | Compatible with all<br>appropriate predicate devices | Compatible with specially<br>designed frames, clamps, rods,<br>couplings, pins, posts, bolts,<br>washers, nuts, & others for the<br>management of appropriate<br>orthopedic surgeries | {2}------------------------------------------------ # Device Comparison Chart Image /page/2/Picture/1 description: The image shows handwritten text on a white background. The top line reads 'k032169', with the 'k' being lowercase and the other characters being numbers. The second line reads 'page 3 of 3', indicating that this is the third page of a three-page document. | Where used | The device is being used in hospitals and in patients surroundings and environments | |------------|-------------------------------------------------------------------------------------| | | Same | . {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white seal. The seal is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized lines that resemble a bird in flight. The lines are thick and curved, and they are arranged in a way that suggests movement. Public Health Service SEP 2 2 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 CyberOrthology, Inc. c/o Mr. Arthur Ward AJW Technology Consultants, Inc. 962 Allegro Lane Apollo Beach, FL 33572 Re: K032169 Trade/Device Name: CyberOrthology Carbon Fiber Composite Circular Fixation (CIRfix) Device (Half Ring) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: June 30, 2003 Received: July 21, 2003 Dear Mr. Ward: 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 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. {4}------------------------------------------------ Page 2 - Ms. Lisa M. Boyle 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 (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 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 yours. Mark M. Wilkerson 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 {5}------------------------------------------------ # 510(k) Number (if known): ## Device Name: CyberOrthology Carbon Fiber Composite Circular Fixation (CIRfix) Device (Half Ring) ### Indications For Use: Open and closed fracture fixation, nonunion, precise control of bone segments location including angulation, rotation, translation, lengthening, and shortening. The External Fixator also aids correction of bone deformities or defects associated with fractures and other pathological conditions of bone. The limb function is preserved if the External Fixator is properly applied. # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ### Concurrence of CDRH, Office of Device Evaluation (ODE) Mark A. Milkman (Division of General, Restorative and Neurological I Number K032169 510(k) Number - OR Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)