M-COR HIP REPLACEMENT SYSTEM

{0}------------------------------------------------ # 510(k) Summary #### SUBMITTED FOR: | Company Name: | Portland Orthopaedics Limited | |--------------------------|--------------------------------------------------------------------------------------------------------| | Address: | Unit 3, 44 McCauley St<br>Matraville, NSW, 2036 Australia | | Telephone: | ++ 61-2-9666-8444 | | Fax: | ++61-2-9666-8544 | | SUBMITTED BY: | Elaine Duncan, M.S.M.E., RAC<br>President, Paladin Medical, Inc.<br>PO Box 560<br>Stillwater, MN 55082 | | Telephone: | 715-549-6035 | | Fax: | 715-549-5380 | | CONTACT PERSON: | Elaine Duncan | | DATE PREPARED: | December 1, 2005; revised April 3, 2006 | | TRADE NAME: | The M-COR Modular Hip System™ | | COMMON NAME: | Hip Replacement System | | CLASSIFICATION NAME & #s | | 21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis 21 CFR 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. # DEVICE PROCODE & PANEL: Orthopaedics 87 : #### DESCRIPTION of the DEVICE: The M-COR (Modular – Center of Rotation) Hip Replacement System is a modular femoral neck and stem component system, to be used for cementless applications. The M-COR Hip Replacement System is comprised of two units: the first is a Commercially Pure Titanium (CPT) coated femoral stem component manufactured from titanium alloy (Ti-6Al-4V). The second is a femoral neck component from either titanium alloy (Ti-6Al-4V) or cobalt-chrome. # SUBSTANTIAL EQUIVALENCE INFORMATION The M-COR Modular Hip System™ described in this submission is substantially equivalent to the predicate devices S-ROM Femoral Hip Stem, the Apex Modular Hip and the Margron Hip Replacement based on similarities of design, intended use, material and manufacturing methods. As demonstrated by the test results and materials information, the differences in the M-COR Modular Hip System™ do not raise any new issues of safety and effectiveness. {1}------------------------------------------------ K053417. (pg 2 of 2) ## 510(k) Summary-Continued #### INDICATIONS FOR USE: The M-COR Modular Hip System™ has the following indications for use: - · The patient should be skeletally mature. - · The patient's condition should be due to one or more of the following: - Osteoarthritis. 1. - 2. Rheumatoid arthritis. - 3. Ankylosing spondylitis - 4. Psoriatic arthritis. - 5. Tumor conditions involving the upper third of the femur or of the acetabulum - Old osteomyelitis with a long infection-free period and a normal WBC, ESR 6. and C-reactive protein. - 7. Non-union of femoral neck fracture or avascular necrosis of the femoral head. - 8. Post-traumatic fracture/dislocation of the hip. - Revision of an unsuccessful arthrodesis with either poor positioning or pain in 9. the hip, or where low back pain or knee pain is becoming disabling. - 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present. - 11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty. #### SUMMARY of TESTING: Portland Orthopaedics, Ltd. has provided analytical and mechanical testing to demonstrate the substantial equivalence of and compliance to standards for the M-COR Modular Hip System™. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 20 2006 Portland Orthopaedics, Ltd. % Paladin Medical, Inc. Ms. Elaine Duncan, M.S.M.E., RAC President P.O. Box 560 Stillwater, Minnesota 55082-0560 Re: K053417 Trade/Device Name: M-COR Modular Hip System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Codes: LZO, LPH, KWY Dated: July 7, 2006 Received: July 10, 2006 Dear Ms. Duncan: 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 {3}------------------------------------------------ #### Page 2 - Ms. Elaine Duncan, M.S.M.E., RAC 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. 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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Saubare (melup Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): 053411 Device Name: M-COR Hip replacement system Indications For Use: The M-COR Modular Hip System has the following indications for use: · The patient should be skeletally mature. · The patient's condition should be due to one or more of the following: - 1. Osteoarthritis. 2. Rheumatoid arthritis. 3. Ankylosing spondylitis 4. Psoriatic arthritis. 5. Tumor conditions involving the upper third of the femur or of the Acetabulum 6. Old osteomyelitis - with a long infection-free period and a normal WBC, ESR and Creactive protein. 7. Non-union of femoral neck fracture or avascular necrosis of the femoral head. 8. Post-traumatic fracture/dislocation of the hip. 9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling. 10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present. 11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty. AND/OR Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Barbara Burns Division of Gene and Neurological Devices 510(k) Number K053417