TRABECULAR METAL KNEE SYSTEM AUGMENTS

{0}------------------------------------------------ Implex Corp DEC 2 1 2004 ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Trabecular Metal Knee System Augments | Submitter Name: | Implex Corp. | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address: | 80 Commerce Drive<br>Allendale, New Jersey 07401-1600 | | Contact Person(s): | Marci Halevi | | Phone Number: | (201) 818-1800 ext 507 | | Fax Number: | (973) 829-0825 | | Date Prepared: | February 23, 2004 | | Device Trade Name: | The Trabecular Metal Knee System Augments | | Device Common Name: | Knee System Augments | | Classification Name: | Prosthesis, knee, patello/femorotibial, semi-constrained,<br>uncemented, porous, coated, polymer/metal/polymer | | Substantial Equivalence: | The term "substantial equivalence" as used in this<br>510(k) notification is limited to the definition of<br>substantial equivalence found in the Federal Food,<br>Drug and Cosmetic Act, as amended and as applied<br>under 21 CFR 807, Subpart E under which a device<br>can be marketed without premarket approval or | A determination of substantial reclassification. equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts. ## Predicate Devices: The NexGen Trabecular Metal Knee System Augments (K024161). {1}------------------------------------------------ ## 510/K) Summary of Safety and Effectiveness - Continued... - System Augments Metal Knee are Device Description: The Trabecular manufactured to be compatible for use with Zimmer's NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System and Zimmer's NexGen Complete Knee Solution - Legacy Knee Constrained Condylar Knee (LCCK) When used with the RHK System, the Trabecular System. Metal Augments are for cemented use only. When used with the LCCK System, the Trabecular Metal Augments are for either cementless or cemented use. - Trabecular Metal Knee System Augments are intended for Intended Use: use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Rotating Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use only. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Augments are for cementless or cemented use. - The predicate and subject devices are identical; performance Performance Data: characteristics therefore remain as documented in the predicate submission (K024161). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other. The faces are connected by a flowing line that resembles a ribbon or wave. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 1 2004 Marci Halevi Manager of Regulatory Affairs Implex Corp. 80 Commerce Drive Allendale, New Jersey 07401-1600 Re: K040487 Trade/Device Name: Trabecular Metal Knee System Augments Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal / polymer porous- coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: September 22, 2004 Received: September 23, 2004 Dear Ms. Halevi: 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. {3}------------------------------------------------ ## Page 2 - Marci Halevi 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 11 you a this office of Compliance at (240) 276-0120. 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, Alan Watts 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 {4}------------------------------------------------ Implex Corp 510(k) Number (if known): Device Name: Trabecular Metal Knee System Augments Indications For Use: Trabecular Metal Knee System Augments are intended for use where severe Trabookal Motar Knoo Or other pathology of the knee joint indicates total knee When used with the NexGen Complete Knee Solution - Rotating arthroplasty. Hinge Knee (RHK) System, the Trabecular Metal Augments are for cemented use Hingo Nhoo (Firm) Cyclen NexGen Complete Knee Solution - Legacy Constrained only. When assuments the Trabecular Metal Augments are for cementless or cemented use. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH; Office of Device Evaluation (ODE) | Prescription | | |----------------------|----------------------------------------------------| | Use | | | (Per 21 CFR 801.109) | <div style="text-decoration: line-through;"></div> | OR... Over-The-Counter Use (Optional Format 1-2-96) Division Division of General, Restorative, and Neurological Devices KO40487 510(k) Number.