REJUVENATE MODULAR HIP SYSTEM

{0}------------------------------------------------ K08/044 # Summary of Safety and Effectiveness Rejuvenate Modular Hip System Line Extension | Proprietary Name: | Rejuvenate Modular Hip System Line Extension | JUN - 3 2008 | |------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------| | Common Name: | Rejuvenate Modular Stem | | | Classification Name and Reference: | Hip prosthesis | | | | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis, 21 CFR §888.3353 | | | | Hip joint metal/polymer/metal semi-constrained porous coated<br>uncemented prosthesis, 21 CFR §888.3358 | | | | Hip joint metal/polymer semi-constrained cemented prosthesis 21<br>CFR §888.3350 | | | | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented<br>prosthesis. 21 CFR §888.3390 | | | | Hip joint metal/polymer constrained cemented or uncemented<br>prosthesis. 21 CFR §888.3310 | | | | Hip joint femoral (hemi-hip) metallic cemented or uncemented<br>prosthesis. 21 CFR §888.3360 | | | Regulatory Class: | Class II | | | Product Codes: | 87 MEH - prosthesis, hip, semi-constrained, uncemented,<br>metal/polymer, non-porous, calcium-phosphate | | | | 87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer,<br>cemented or non-porous, uncemented | | | | 87 LPH - prosthesis, hip, semi-constrained, metal/polymer, porous<br>uncemented | | | | 87 JDI - prosthesis, hip, semi-constrained, metal/polymer, cemented | | | | 87 KWY - prosthesis, hip, hemi-, femoral, metal/polymer, cemented<br>or uncemented | | | | 87 KWZ - prosthesis, hip, constrained, cemented or uncemented,<br>metal/polymer | | | | 87 KWL - prosthesis, hip, hemi-, femoral, metal | | | | 87 LWJ - prosthesis, hip, semi-constrained, metal/polymer,<br>uncemented | | : . . . {1}------------------------------------------------ For Information contact: Denise Daugert, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5413 Fax: (201) 831-6038 Date Prepared: April 11, 2008 #### Description: This Special 510(k) submission is a line extension to address modifications to the Stryker Modular Hip System. This line extension extends the combined head/neck length options. #### Intended Use The Stryker Modular Hip is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used with any currently available Howmedica Osteonics acetabular components, V40 femoral heads, C-Taper Alumina heads when used with the V40/C-Taper Adaptor and the Biolox® Delta Universal Taper Heads and sleeves. #### Indications The indications for use of total hip replacement prostheses include: - Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 1) - 2) Rheumatoid arthritis; - Correction of functional deformity; 3) - Revision procedures where other treatments or devices have failed; and, 4) - Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head ર) involvement that are unmanageable using other techniques. This hip is intended for cementless use only. ### Substantial Equivalence: With the addition of this line extension The Rejuvenate Modular Hip System is substantially equivalent to the Stryker Modular Hip cleared under K07182 in regards to intended use, design, materials, and operational principles as a hip prosthesis. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Howmedica Osteonics Corp. % Ms. Denise Daugert Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430 JUN - 3 2008 K081044 Trade/Device Name: Rejuvenate 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 Code: MEH, LZO, LPH, JDI, KWY, KWZ, KWL, LWJ Dated: May 13, 2008 Received: May 14, 2008 Dear Ms. Daugert: Re: 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 - Ms. Denise Daugert This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence 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 N. Mullison 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): 《ΟΥΊΟΥΎ Device Name: Rejuvenate Modular Hip System Indications for Use: The indications for use of total hip replacement prostheses include: Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 1) - Rheumatoid arthritis; 2) - Correction of functional deformity; 3) - Revision procedures where other treatments or devices have failed; and, 4) - Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head 5) involvement that are unmanageable using other techniques. This hip is intended for cementless use only. | Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | |-------------------------------------------------|---| | AND/OR | | | Over-The-Counter Use<br>(21 CFR 807 Subpart C) | | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Nilke Oden for nxn (D: size, bss Division of General, Restorative, and Neurological Devices 510(k) Number_