CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY

{0}------------------------------------------------ K110836 (pg. i of 3) Image /page/0/Picture/1 description: The image shows a logo with the letter Z inside of a circle. The letter Z is stylized with sharp angles and lines. Below the circle is the word "zimmer" in a sans-serif font, with each letter outlined. OCT - 7 2011 P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131 #### 510(k) Summary Zimmer, Inc. SulzerAllee 8 CH-8404 Winterthur, Switzerland Daniel J. Williman Specialist, Regulatory Affairs Telephone: 574-371-8065 Fax: (574) 372-4605 September 28, 2011 CLS® Brevius™ Stem with Kinectiv® Technology LZO - Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented LPH - Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented KWA - Prosthesis, hip, semi-constrained (metal uncemented acetabular component) JDL - prosthesis, hip, semi-constrained (metal cemented acetabular component) LWJ - Prosthesis, hip, semi-constrained, metal/polymer, uncemented KWZ - prosthesis, hip, constrained, cemented or uncemented, metal/polymer JDI - prosthesis, hip, semi-constrained, metal/polymer, cemented 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Sponsor: Contact Person: Date: Trade Name: Product Code / Device: Regulation Number / Description: {1}------------------------------------------------ K110836 (pg. 2 of 3) 21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis 21 CFR § 888.3330 - Hip joint metal/metal semiconstrained, with an uncemented acetabular component, prosthesis 21 CFR 888.3320 - Hip joint metal/metal semiconstrained, with a cemented acetabular component, prosthesis 21 CFR 888.3360 - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 21 CFR § 888.3310 - Hip joint metal/polymer constrained, cemented or uncemented prosthesis 21 CFR § 888.3350 - Hip joint metal polymer, semi-constrained cemented prosthesis CLSTM Spotorno™ Femoral Stem, manufactured by Zimmer Austin, Inc., K042249, cleared September 15, 2004 Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology System, manufactured by Zimmer Inc., K081007, cleared May 6, 2008 Zimmer® M/L Taper Hip Prosthesis with Kinectiv™ Technology System, manufactured by Zimmer Inc., K071856, cleared July 30, 2007 Zimmer® M/L Taper Hip Prosthesis with Modular Neck Technology, manufactured by Zimmer Inc. K063251, cleared January 24, 2007 The CLS Brevius Stem with Kinectiv Technology is a modular, titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design with a proximal-to-distal taper and a trapezoidal cross-section. The proximal portion of the stem contains a tapered female junction to allow for attachment to Kinectiv Technology modular necks and features for attachment of insertion/extraction Device Description: Predicate Device: {2}------------------------------------------------ K110836 (pg. 3 of 3) instrumentation. Total hip replacement for patients with: - · Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - · Femoral neck fractures. - · Failed previous surgery where pain, deformity, or dysfunction persists. - · Revision of previously failed hip arthroplasty. Hemi-hip replacement for patients with: - · Femoral neck fractures. This femoral stem is for cementless use only. Comparison to Predicate Device: Performance Data (Nonclinical and/or Clinical): The CLS Brevius system is similar or identical in intended use, materials, sterility, and performance characteristics to the predicate device(s). Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing/analysis included: Proximal Stem Fatigue Test (including Finite Element Analysis to determine the worst case device for this test), Distal Stem Fatigue Evaluation, Primary Stability Test, Influence of Version Analysis, Accelerated Corrosion Fatigue Test, Distraction Test, and MR Evaluation. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device. Intended Use: {3}------------------------------------------------ Image /page/3/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 three lines representing its wings and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The eagle is facing to the right, and the text is arranged around the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Zimmer, Inc. % Mr. Daniel Williman Associate Project Manager, Regulatory Affairs P.O. Box 708 Warsaw. Indiana 46581-0708 OCT - 7 2011 Re: K110836 Trade/Device Name: CLS® Brevius™ Stem with Kinectiv® Technology Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acctabular component, prosthesis Regulatory Class: Class III Product Code: KWA, JDL, LZO, LPH, LWJ, KWZ, JDI Dated: September 28, 2011 Received: September 29, 2011 Dear Mr. Williman: 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 net 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 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 (2 i CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical {4}------------------------------------------------ # Page 2 – Mr. Daniel Williman device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/Reportal/roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Sincerely yours, Mark N. Melkerson Director Division of Surgical, Orthoped and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K110836 # Indications for Use #### 510(k) Number (if known): ### Device Name: CLS® Brevius™ Stem with Kinectiv® Technology ## Indications for Use: Total hip replacement for patients with: - Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, . osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - . Femoral neck fractures. - . Failed previous surgery where pain, deformity, or dysfunction persists. - Revision of previously failed hip arthroplasty. . Hemi-hip replacement for patients with: - Femoral neck fractures. . This femoral stem is for cementless use only. Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) 12 (Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |---------------------|--| |---------------------|--| Division of Surgical, Orthopedic, and Restorative Devices | Page 1 of 1 | | |-------------|--| |-------------|--| | 510(k) Number | K110836 | |---------------|---------| |---------------|---------|