DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

{0}------------------------------------------------ # K083642 (pg 1/2) # MAR 6 2009 # 510 (k) Summary (As required by 21 CFR 807.92 and 21 CFR 807.93) #### NAME OF SPONSOR: 510(K) CONTACT: DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910 Dawn Sinclair Regulatory Affairs Associate Telephone: (574) 372-5023 Facsimile: (574) 371-4987 Electronic Mail: Dsincla3@its.jnj.com DATE PREPARED: PROPRIETARY NAME: COMMON NAME: CLASSIFICATION: December 5, 2008 87 KWA DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners Acetabular Cup Prosthesis Class III per 21 CFR 888.3330, Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis #### DEVICE PRODUCT CODE: SUBSTANTIALLY EQUIVALENT DEVICE(S): DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K062426 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K023786 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K003523 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K002883 Biomet® Metal-on-Metal Hip Systems, K082446 {1}------------------------------------------------ K083642.(pg 2/2) ## DESCRIPTION: The subject of this 510(k) consists of modifications to the Instructions for Use (IFU). The following two contraindications and potential adverse effect have been added to the IFU. DePuy Orthopaedics is making these IFU revisions to comply with a request from Health Canada, as well as to update the contents to reflect current industry practice. These are the only changes to the labeling and IFU; there are no changes to the device design. Contraindications: - Use is contraindicated in cases with chronic renal failure. . - Females of childbearing age are contraindicated due to the unknown effects of . elevated levels of metal ions on the fetus. Potential adverse effect: - The potential long-term biological effects of metal wear debris and metal ion . production are not known. No changes have been made to the Indications for Use or the Intended Use of this device. # INDICATIONS AND INTENDED USE: ## Indications: The Pinnacle Metal-on-Metal Acetabular Cup Liners are indicated for use as the acetabular component in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. #### Intended Use: The Pinnacle Metal-on-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DePuy Orthopaedics, Inc. % Ms. Dawn Sinclair Regulatory Associate, Regulatory Affairs 700 Orthopaedic Dr. Warsaw, Indiana 46581 MAR 6 2009 Re: K083642 Trade/Device Name: DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint, metal/metal semi-constrained, with an uncemented acctabular component, prosthesis Regulatory Class: III Product Code: KWA Dated: December 8, 2008 Dear Ms. Sinclair: Received: December 9, 2008 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. Dawn Sinclair 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark M. Millican 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 Statement 510 (k) Number (if known): 16083642 (po 1/1) Device Name: DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners #### Indications for Use: The Pinnacle Metal-on-Metal Acetabular Cup Liners are indicated for use as the acetabular component in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, silipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Pinnacle Metal-on-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) () x Sh Yo (Please do not write below this line. Continue on another page if needed.) Concurrence of CDRH, Office of Device Evaluation (ODE) (Posted November 13, 2003) CDRH, Office of Device Evaluation (ODE) Mark H. Milliken Page 1 of 1 (Division Sign-Off) Division of General, Restorative, and Neurological Devices 0000 510(k) Number