BIOLOX delta Option and Extra-long Heads

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 6, 2018 MicroPort Orthopedics Inc. Allen Mamaril Regulatory Affairs Specialist I 5677 Airline Road Arlington, Tennessee 38002 Re: K173776 Trade/Device Name: BIOLOX delta Option and Extra-long Heads 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 Dated: June 1, 2018 Received: June 4, 2018 Dear Allen Mamaril: 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K173776 Device Name BIOLOX® Delta Option and Extra-long Heads Indications for Use (Describe) MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. 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) # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue square with a red star inside, followed by the text "MicroPort" in blue and "Orthopedics" in red. Below the logo is the text "MicroPort Orthopedics Inc." in black. # 510(K) Summary In accordance with the Food and Drug Administration Rule to implement provisions of Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the BIOLOX® delta Option and Extra-long Heads. | Submitted by: | MicroPort Orthopedics Inc.<br>5677 Airline Rd, Arlington, TN, 38002<br>Phone 866-872-0211<br>Fax: 855-466-2247 | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | December 11, 2017 | | Contact Person: | Allen Mamaril<br>Regulatory Affairs Specialist I | | Proprietary Name: | BIOLOX® delta Option and Extra-long Heads | | Common Name: | Femoral Head, Neck Sleeve | | Classification Name and Reference: | 21 CFR 888.3353 – Hip joint metal/ceramic/polymer semi-<br>constrained<br>cemented or nonporous uncemented<br>prosthesis—Class II | | Subject Product Code and Panel Code: | Orthopedics/87/LZO | | Predicate Device: | Femoral Head:<br>K130376 DYNASTY® Acetabular System with Ceramic<br>Neck Sleeve:<br>K072656 DYNASTY® Acetabular System | | Reference Device: | Femoral Head:<br>K140043 DYNASTY® Acetabular System with Ceramic<br>K953025 SLT 28mm XXL Femoral Head<br>K141653 Biolox® delta Option Ceramic Heads<br>K131684 Biolox® delta Ceramic heads<br>K131518 Mectacer Biolox Option Heads<br>K112115 Mectacer Biolox Delta Heads<br>Neck Sleeve:<br>K141653 Biolox® delta Option Ceramic Heads<br>K131518 Mectacer Biolox Option Heads | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue square with a red star inside, followed by the text "MicroPort" in blue and "Orthopedics" in red. Below the logo, the text "MicroPort Orthopedics Inc." is written in a smaller font. #### DEVICE INFORMATION # A. Intended Use MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia; - 2. inflammatory degenerative joint disease such as rheumatoid arthritis; - 3. correction of functional deformity; and, - revision procedures where other treatments or devices have failed. 4. # B. Device Description The BIOLOX® delta Option and Extra-long Heads include femoral heads and neck sleeves. The design features are summarized below: - Femoral Heads ● - BIOLOX® delta Option: o - Manufactured from alumina matrix composite - Head sizes: 28mm, 32mm, 36mm, 40mm, 44mm ■ - Conical Bore: 16/18 Taper - BIOLOX® delta Extra-long: o - Manufactured from alumina matrix composite ■ - Head Sizes: 32mm, 36mm, 40mm - 트 Conical Bore: 12/14 Taper - Neck Sleeves - o BIOLOX® delta Option: - Manufactured from titanium alloy ■ - 트 Neck Sleeve sizes: Short, Medium, Long, and Extra-long - . Conical Bore: 16/18 External Taper, 12/14 Internal Taper #### C. Substantial Equivalence Information The design features and materials of the BIOLOX® delta Option and Extra-long Heads are substantially equivalent to those of the predicate devices cleared under K130376 and K072656. The indications of the subject devices are identical to the predicates. The fundamental scientific technology of the subject devices has not changed relative to the predicate devices. The safety and effectiveness of subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. # D. Nonclinical Testing The subject BIOLOX® delta Option femoral heads were evaluated mechanically for static (or pre-fatigue) burst strength and post-fatigue burst strength. The subject devices were evaluated for the stability of the taper system subjected to traction forces between the BIOLOX® delta Option femoral head and BIOLOX® delta Option neck sleeve by conducting an axial pull off test to measure distraction forces. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a red diamond shape. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" underneath in red. Below the logo is the text "MicroPort Orthopedics Inc." Rotational stability tests were also performed to measure the torque required to twist the BIOLOX® delta Option femoral head on the tapers. Lastly, the subject devices were tested for fretting corrosion of the BIOLOX® delta Option sleeve and tapers of the stem/neck mating components. # E. Clinical Testing Clinical data was not provided for the subject devices. # F. Biocompatibility Biocompatibility information for the subject devices is included in the cited Master File. The intended patient contact, materials, colorants, manufacturing steps and processing additives used in the subject implant devices are identical to those of the predicate and reference devices. Therefore, additional biocompatibility testing was not completed on the subject devices. The subject devices are implanted using existing specialized trial and impactor instruments, for which colorant and biocompatibility information were reviewed by FDA in K170444. # G. Component and Accessory Compatibility Tables 1 and 2 show the compatibility of the subject devices with previously cleared MicroPort Orthopedics products. #### Table 1. Compatible Shells and Liners, Including 510(k) information | 510(k) | Device Name | |---------|--------------------------------------------| | K061547 | DYNASTY® Beaded Shells and Liners | | K070785 | DYNASTY® Beaded Shells and Liners | | K082924 | DYNASTY® BIOFOAM® Shells and Liners | | K122382 | DYNASTY® BIOFOAM® Shells and Liners | | K142119 | PROCOTYL® L Beaded Shells and Liners | | K170444 | PROCOTYL® PRIME Shell and Liners | | K171181 | PROCOTYL® PRIME E-CLASS™ Shells and Liners | #### Table 2. Compatible Femoral Components, Including 510(k) Information | 510(k) | Device Name | |---------|-------------------------------| | K003016 | PRO-FEMUR R | | K012091 | PRO-FEMUR | | K021346 | STEM HIP REPLACEMENT SYSTEM | | K041114 | PROFEMUR TAPERED HIP STEM | | K041586 | PROFEMUR S HIP STEM | | K051995 | PROFEMUR RENAISSANCE HIP STEM | | K052915 | PROFEMUR XTR HIP STEM | | K053588 | PROFEMUR LX HIP STEM | | K060358 | PROFEMUR TL HIP STEM | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image contains the logo for MicroPort Orthopedics Inc. The logo features a blue square with rounded corners and a red star inside. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. The text "MicroPort Orthopedics Inc." is below the logo. | K080663 | PROFEMUR LX REVISION 5/8 COATED HIP STEM | |---------|--------------------------------------------------| | K081090 | PROFEMUR LX 5/8 COATED HIP STEM | | K091423 | PROFEMUR HIP SYSTEM MODULAR NECKS | | K100866 | PROFEMUR HIP SYSTEM MODULAR NECKS | | K110399 | GLADIATOR PLASMA CLASSIC HIP STEM | | K111698 | PROFEMUR(R) E CEMENTLESS HIP STEM | | K111699 | PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM | | K111910 | GLADIATOR HIP STEM | | K112080 | PRESERVE HIP STEM | | K112150 | PROFEMUR GLADIATOR HA HIP STEM | | K121221 | PROFEMUR Z REVISION HIP STEM | | K123434 | PROFEMUR Z CLASSIC STEM | | K123688 | PROFEMUR TL CLASSIC STEM | | K130984 | PROFEMUR RENAISSANCE CLASSIC STEM | | K140676 | PROFEMUR TL CLASSIC LONG NECK HIP STEMS | | K141235 | PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS | | K150133 | PROFEMUR PRESERVE SIZE 1-3 HIP STEMS | | K150302 | PROFEMUR PRESERVE CLASSIC STEM | # H. Conclusions The safety and effectiveness of the BIOLOX® delta Option and Extra-long Heads are adequately supported by the substantial equivalence information, materials information, and nonclinical testing data provided within this premarket notification.