FIDJI SMALL CEMENT RESTRICTOR

{0}------------------------------------------------ DEC 2 2 2003 # 510(k) SUMMARY #### SUBMITTED BY Diane Johnson Spine Next America 4720 Salisbury Road Suite 135 Jacksonville, FL 32256 March 7, 2003 Date Submitted: ### CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME | Classification Name: | Prosthesis, Hip, Cement Restrictor | |-------------------------|------------------------------------| | Common/Usual Name: | Cement Restrictor | | Product Classification: | Class II | | Proprietary Name: | Fidji Small Cement Restrictor | ### PREDICATE DEVICE Cement Restrictor (CR) manufactured by Medtronic Sofamor Danek USA, Inc. [reference 510(k) K013663 cleared December 5, 2001] This summary of 510(k) safcty and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92. # DEVICE DESCRIPTION AND MATERIALS OF CONSTRUCTION The Fidji Small Cement Restrictor is a hollow, trapezoidal block that is machined from cxtruded Polyetherctherketone (PEEK), which complies with ASTM F202. It contains a titanium alloy, removable anchor that is designed to aid in maintaining its position within the medullary space of the femur or humerus. It also contains tantalum inserts that serve as location and orientation markers for radiographs. #### INDICATIONS FOR USE This device is intended for use in conjunction with standard PMMA cement. The Fidji Small Cement Restrictor is designed to occlude the medullary canal before the introduction of PMMA cement during surgeries such as arthroplasty. It is also designed to prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. {1}------------------------------------------------ # THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED. #### COMPARISON TO THE PREDICATE DEVICE In general, both the Spine Next Fidji Small Cement Restrictor and its predicate device, the Medtronic Sofamor Danek Ccment Restrictor, are devices that are used as for occlusion of the medullary canal before the introduction of PMMA cement during surgeries such as total hip arthroplasty, as well as for the prevention of cement from flowing down the diaphysis thereby facilitating cement pressurization. Neither of theses devices is intended for use in spinal indications. Technologically they are virtually identical in their function and principle of operation. Both devices are similar in that they are not intended for use under load conditions. They both serve as a cement restrictor in the medullary canal with similar surgical techniques for implantation. Both devices have similar mechanical compression characteristics since their material of construction is identical. The Spine Next Fidji Small Cement Restrictor Device is substantially Conclusion: equivalent to the Medtronic Sofamor Danek Cement Restrictor (K013663) based upon the devices' similarities in functional design, performance, safety, and indications-for use. {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # DEC 2 2 2003 Ms. Diane Johnson Director, Regulatory Affairs Spine Next America Corporation 104 Greenwood Creek Road Queenstown, Maryland 21658 Re: CK03076 Dand K030871 FIDJI Small Cement Restrictor and FIDJI Large Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: JDK Dated: November 3, 2003 Received: November 4, 2003 Dear Ms. Johnson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 provisious of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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. The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. {3}------------------------------------------------ Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label: ### WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. # THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED. 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. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described. Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling. {4}------------------------------------------------ Page 3 - Ms. Diane Johnson 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 yours, M Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health . Enclosures (2) {5}------------------------------------------------ 510(k) Number (if known): Device Name: Spine Next® Fidji® Small Cement Restrictor #### Indications for Use: The Fidji Small Cement Restrictor is intended for use in conjunction with standard PMMA cement and is designed to occlude the medullary canal during the introduction of the cement during surgeries such as arthroplasty. It is also designed to prevent cement from flowing down the diaphysis thereby facilitating cement pressurization. THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED. ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark A. Miller vision Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K030767 Prescription Use (PER 21 CFR 801.109) OR Over-The-Counter Use Optional Format 1-2-96