Alpine Cemented Hip System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three faces in profile, stacked on top of each other. The faces are black and are oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 18, 2016 Ortho Development Corporation Drew Weaver Director of Quality Assurance and Regulatory Affairs 12187 South Business Park Drive Draper, Utah 84020 Re: K153216 Trade/Device Name: Alpine® Cemented Hip System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, KWL, KWY, LPH, LZO, MBL Dated: November 3, 2015 Received: November 5, 2015 Dear Drew Weaver: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 (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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use See PRA Statement below. Pg.1/1 510(k) Number (if known) #### Device Name Alpine® Cemented Hip System #### Indications for Use (Describe) This device is intended for use in total and hemi hip arthroplasty. The device is intended for single, cemented use only in cases of: - 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis. - 2. Previously failed hip surgery. - 3. Proximal femoral neck fractures or dislocation. - 4. Idiopathic avascular necrosis of the femoral head. - 5. Non-union of proximal femoral neck fractures. - 6. Treatment of fractures that are unmanageable using other forms of therapy. 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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}------------------------------------------------ 12187 So. Business Park Drive Draper, Utah 84020 801-553-9991/fax 553-9993 orthodevelopment.com Image /page/3/Picture/2 description: The image is a logo for "Ortho Development". The logo features a stylized purple circle with three curved lines emanating from it, followed by the word "ORTHO" in purple, block letters. Below "ORTHO" is the word "DEVELOPMENT" in a smaller, gray font with a trademark symbol. ## Section 5 510(k) Summary | Name of Sponsor: | Ortho Development Corporation<br>12187 South Business Park Drive<br>Draper, Utah 84020 | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Contact: | Drew Weaver<br>Director of Quality Assurance and Regulatory Affairs<br>Telephone: (801) 553-9991<br>Facsimile: (801) 553-9993<br>Email: DWeaver@orthodevelopment.com | | Date Prepared: | February 17, 2016 | | Trade Name: | Alpine® Cemented Hip System | | Common Name: | Total and Hemi Hip Replacement Prosthesis | | Device Product<br>Code/Classification: | JDI- 21 CFR 888.3350, Hip joint metal/polymer semi-constrained cemented<br>prosthesis | | Subsequent Device<br>Product<br>Codes/Classifications: | KWL- 21 CFR 888.3360, Hip joint femoral (hemi-hip) metallic cemented or<br>uncemented prosthesis | | | KWY- 21 CFR 888.3390, Hip joint femoral (hemi-hip) metal/polymer cemented<br>or uncemented prosthesis | | | LPH- 21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis | | | LZO- 21 CFR 888.3353, Hip joint metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented prosthesis | | | MBL- 21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis | | Device Class: | Class II | | Predicate Devices: | Encompass™ Cemented Hip System, K050637, Ortho Development Corporation<br>Synergy Cemented Hip Stems, K990369, Smith & Nephew | {4}------------------------------------------------ ## Device Description Alpine® Cemented Hip System is comprised of a single piece, conical tapered, collared, femoral hip stem and centralizer designed for single, cemented use. Alpine® Cemented Hip Stem is manufactured from cobalt-chrome alloy (per ASTM F799-11) and Alpine® Centralizer is manufactured from poly(methyl methacrylate), PMMA. See MAF-300, PolyOne Corporation. Device fixation is achieved by cement mantle in the medullary canal. Alpine® Cemented Hip Stem has a neck with a 12/14 trunnion for modular attachment to femoral heads and is offered in a variety of sizes to accommodate various patient anatomies. Sizes include the following ranges: lengths (114-132mm), horizontal offsets (35-48mm), and vertical offsets (26-30mm), with a resection angle of 40° and a neck angle of 130°. Alpine® Centralizer is offered in sizes 8mm to 18mm in diameter to accommodate various combinations of stem/centralizer diameters depending on surgeon preference. ### Intended Use Alpine® Cemented Hip System is intended for use in total and hemi hip replacement surgery. ### Indications for Use This device is intended for use in total and hemi hip arthroplasty. The device is intended for single, cemented use only in cases of: - 1. Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis - 2. Previously failed hip surgery - 3. Proximal femoral neck fractures or dislocation - 4. I ldiopathic avascular necrosis of the femoral head - 5. Non-union of proximal femoral neck fractures - 6. Treatment of fractures that are unmanageable using other forms of therapy - 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis ### Summary of Technological Characteristics Alpine® Cemented Hip System has the same technological characteristics as the predicate devices. Subject device stem is single piece, conical tapered, and collared. The proximal body has a recess in the anterior and posterior walls to aid in proximal cement fixation. The distal body has flattened geometries in the anterior and posterior walls to aid in distal cement fixation. The highly polished neck has an oval cross section for increased range of motion. Subject device centralizer uses a tapered pin for fixation with the stem. It has 3 fins that aid in centering the stem within the medullary canal. {5}------------------------------------------------ ## Basis of Substantial Equivalence Alpine® Cemented Hip System is substantially equivalent to previously cleared predicate devices based on similarities in intended use, overall design, materials, manufacturing methods, packaging, mechanical performance, and sterilization. #### Non-Clinical Test Summary Non-clinical performance testing has been conducted in proximal fatigue in accordance with ISO 7206-6:2013(E) and distal fatigue in accordance with ISO 7206-4:2010(E). Range of motion analysis was performed per ISO 21535:2007(E). #### Clinical Test Summary No clinical studies were performed. #### Conclusions Based on the similarities to the predicate devices, and a review of testing, Alpine® Cemented Hip System is substantially equivalent to predicate devices cleared in K050637 and K990369.