Zimmer M/L Taper Hip Prosthesis

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 26, 2016 Zimmer, Inc. Ms. Rhonda Myer Project Manager. Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581 Re: K161830 Trade/Device Name: Zimmer M/L Taper Hip Prosthesis 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: LZO, MEH Dated: September 23, 2016 Received: September 26, 2016 Dear Ms. Myer: 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). 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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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {1}------------------------------------------------ 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. 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Sincerely, Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson -S" in a simple, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The letters are clear and legible, with consistent spacing between them. Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K161830 (Page 1 of 1) Device Name M/L Taper Hip Prosthesis #### Indications for Use (Describe) Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, traumatic arthritis, polyarthritis, collagen disoular necrosis of thefemoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: fracture dislocation of the hip; debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head: pathological fractures of the femoral neck: and osteoarthritis in which the femoral head is primarily affected. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K161830 Image /page/3/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo features a stylized blue letter "Z" enclosed within a blue circle. Below the circle, the word "zimmer" is written in lowercase, also in blue, with a distinctive font. # 510(k) Summary | Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Rhonda Myer<br>Project Manager, Regulatory Affairs<br>Telephone: (574) 371-9659<br>Fax: (574) 372-4710 | | Date: | June 30, 2016 | | Trade Name: | M/L Taper Hip Prosthesis | | Product Code / Device: | LZO - Prosthesis, Hip, Semi-Constrained,<br>Metal/Ceramic/Polymer, Cemented or Non-Porous,<br>Uncemented | | | MEH - Prosthesis, Hip, Semi-Constrained,<br>Uncemented, Metal/Polymer, Non-Porous,<br>Calcium-Phosphate | | Regulation Number / Description: | 21 CFR § 888.3353 - Hip joint<br>metal/ceramic/polymer semi-constrained cemented<br>or nonporous uncemented prosthesis. | | Predicate Device: | M/L Taper Hip Prosthesis, K032726 (cleared<br>October 22, 2003) and K042337 (cleared November<br>4, 2004) | | Device Description: | The Zimmer M/L Taper Hip Prosthesis is a<br>modular, titanium alloy femoral stem designed to<br>replace the proximal femur in total hip arthroplasty.<br>It is flat, collarless and features a proximal-to-distal<br>taper in the mediolateral (M/L) plane. The wedge-<br>shaped prosthesis is designed for cementless use. | {4}------------------------------------------------ and is circumferentially porous-coated with titanium alloy plasma spray over the proximal body region. A subset of the subject devices are coated with Calcicoat hydroxyapatite tricalcium phosphate coating (HA/TCP) over the porous coating. Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated: irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected. Comparison to Predicate Device: Intended Use: The subject M/L Taper Hip Prosthesis is identical to the predicate devices in design, material, geometry, plasma spray and HA/TCP coatings. The subject device is packaged and sterilized using the same materials and processes as the predicate devices. The subject device also has the same intended use, indications for use, and fixation methods as the predicate devices. The only differences between the subject and predicate devices are the changes in the manufacturing process, which include using a forged blank instead of a wrought blank, using mass disc finishing in addition to hand polishing, and a change to the laser etch type and location. {5}------------------------------------------------ Performance Data (Nonclinical and/or Clinical): Non-clinical performance testing demonstrated that the M/L Taper Hip Prosthesis meets performance requirements. Performance testing performed included proximal fatigue testing to ISO 7206-6 and distal fatigue testing to ISO 7206-4. Bacterial endotoxin testing was conducted and met the endotoxin limits as described in USP39-NF34 Chapter 161. Clinical data and conclusions were not needed for this device.