Prime E-CLASS XLPE Liner

{0}------------------------------------------------ September 14, 2018 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services logo. To the right of the symbol is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. MicroPort Orthopedics Inc. Sarah Stroupe Sr. Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002 Re: K181598 Trade/Device Name: Prime E-CLASS XLPE Liner 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 15, 2018 Received: June 18, 2018 Dear Sarah Stroupe: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR {1}------------------------------------------------ 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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, Vesa Vuniqi -S Digitally signed by Vesa Vuniqi -S Date: 2018.09.14 18:13:22 -04'00' - For: 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) K181598 Device Name Prime E-CLASS™ XLPE Liner #### Indications for Use (Describe) Indications for Use 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. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty. 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. 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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}------------------------------------------------ Image /page/3/Picture/0 description: The image is the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a white circle with a red diamond shape in the center. To the right of the square is the text "MicroPort" in a large, bold, blue font. Below that is the word "Orthopedics" in a smaller, red font, and below that is the phrase "Full Function. Faster" in a smaller, blue font. # 510(k) Summary In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Substantial Equivalence for the use of the Prime E-CLASS™ XLPE Liner. | Submitted by: | MicroPort Orthopedics Inc.<br>5677 Airline Rd, Arlington TN, 38002<br>Phone: 866-872-0211<br>Fax: 855-446-2247 | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Date: | August 30, 2018 | | Contact Person: | Sarah Evonne Stroupe<br>Sr. Regulatory Affairs Specialist | | Proprietary Name: | Prime E-CLASS™ XLPE Liner | | Common Name: | Acetabular Liner | | Classification Name and Reference: | 21 CFR 888.3353 LZO, OQI<br>Hip joint metal/ceramic/polymer semi constrained<br>cemented or nonporous, uncemented prosthesis<br>Class II | | | 21 CFR 888.3358 LPH, OQG<br>Hip joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis<br>Class II | | Subject Product Code and Panel Code: | Orthopedics/87/LZO, LPH, OQG, OQI | | Predicate Devices: | PROCOTYL® PRIME E-CLASS™ XLPE Liner<br>(K171181)<br>Prime Acetabular Cup System XLPE Liner<br>(K180798) | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red four-pointed star. To the right of the square is the text "MicroPort" in blue, with "Orthopedics" in red below it. Below that is the text "Full Function, Faster" in blue. Reference Devices: PROCOTYL® PRIME Acetabular Cup System (K170444) LINEAGE® Acetabular System (K002149 and K052026) DYNASTY® Acetabular System (K002149, K061547, K070785, and K082924) # DEVICE INFORMATION ## A. Intended Use The Prime E-CLASS™ XLPE Liner is an acetabular liner intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. This device is indicated for the following conditions: - 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion 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. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty. ## B. Device Description The Prime E-CLASS™ XLPE Liner is an additional liner option for MicroPort Orthopedics' Prime Acetabular Cup System (K170444; K180798). The subject Liner is intended to be used with Acetabular Shells and optional Cancellous Bone Screws as part of a total acetabular system. The Prime E-CLASS™ XLPE Liner is manufactured from E-CLASS™, a vitamin E blended XLPE, conforming to ASTM F2695-12. The subject Liner is available in Standard, Lipped, and Lateralized/Face-changing configurations. The subject Liner has a two-part locking detail featuring 12 anti-rotational tabs and a lock flange, which is intended to mate with the 12 antirotational pockets and lock groove of the compatible Prime Acetabular Shells (K170444; K180798). {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the word "MicroPort" in blue, with the word "Orthopedics" underneath in red. Below that is the phrase "Full Function, Faster" in blue. ## C. Substantial Equivalence Information The subject Liner's intended use, size range, articulating surface, and available configurations are identical to the predicates K171181 and K180798. The subject Liner's material (E-CLASS™) is identical to the predicate K171181. The subject Liner's geometry is identical to the predicate K180798. The fundamental scientific technology of the subject Liner has not changed relative to the predicates. Based on these similarities, the Prime E-CLASS™ XLPE Liner is believed to be substantially equivalent to the predicate devices. ## D. Nonclinical Testing Nonclinical testing performed on the to establish the basis for substantial equivalence of the Prime E-CLASS™ XLPE Liner included bacterial endotoxin testing and mechanical testing of the lock detail. - . Bacterial endotoxin testing was performed per ANSI/AAMI ST72:2011; endotoxins were found to be less than the USP endotoxin limit of 20 EU/device; - . Mechanical testing of the lock detail was performed through Pre- and Post- Fatigue Pushout Lever-out and Torque-out of the subject Liner from a compatible Shell (K170444; K180798) per ASTM F1820, ASTM STP1301, and testing found in literature. Axial long-term fatigue per FDA Draft Guidance Documents "Guidance Document for Testing Acetabular Cup Prostheses" and "Guidance Document for Testing Non-Articulating 'Mechanically-Locked' Modular Implant Components", both issued May 1, 1995, was also evaluated as part of this study. Due to the subject Liner's identical material and articulating surface, the following testing performed for K171181 is considered applicable: - Material properties of E-CLASS™ per ASTM D1505, ISO 11542-2, ASTM D638, ISO ● 527-3, ASTM D256, ASTM F648, ASTM F2214, ASTM F2138, ASTM F2102-13, ISO 5834-4, ASTM F2381, ASTM F2625, ASTM D3418, ASTM D638, ASTM D695, ISO 5834-3, ISO 5834-5, and ASTM E647; - Smooth wear per ASTM F1714-96 (2003), ISO 14242-2: 2016, ISO 21535: 2007, ISO ● 14242-3:2009, and FDA Guidance "Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices" issued February 12, 2016; - Abrasive wear per ASTM F1714-96 (2003), ISO 14242-3: 2014, ISO 14242-2: 2016, ISO ● 21535: 2007, and ISO 21534: 2007; - Wear particle analysis per ASTM F1877-05; ● {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for MicroPort Orthopedics. The logo features a blue square with rounded corners on the left side, inside of which is a red diamond shape with a white outline. To the right of the square is the text "MicroPort" in a bold, blue font, with the word "Orthopedics" underneath in a red font. Below that is the text "Full Function, Faster" in a blue font. - Long-term fatigue per FDA Draft Guidance Documents "Guidance Document for Testing . Acetabular Cup Prostheses" and "Guidance Document for Testing Non-Articulating 'Mechanically-Locked' Modular Implant Components", both issued May 1, 1995; and, - Deformation and frictional torque per ISO 7206-12. ● Due to the subject Liner's identical articulating surface and configurations, the following testing performed for K170444 is considered applicable: - Range of motion per ISO 21535 ● ## E. Clinical Testing Clinical data was not necessary to determine substantial equivalence between the Prime E-CLASS™ XLPE Liner and the predicate devices. ## F. Biocompatibility The Prime E-CLASS™ XLPE Liner is manufactured from the identical E-CLASS™ material characterized for the predicate K171181. Intended patient contact also remains identical. Therefore, biocompatibility testing performed for K171181 remains applicable to the subject device. Biocompatibility bench and animal studies used to characterize the E-CLASS™ material included extractables, cytotoxicity, irritation, and sensitization studies. The Prime E-CLASS™ XLPE Liner is implanted using the same instrumentation cleared within K170444; no new biocompatibility assessment is required. ## G. Component and Accessory Compatibility The Prime E-CLASS™ XLPE Liner is compatible with Prime Acetabular Cup System Shells (K170444; K180798) and Instrumentation (K170444). The Prime E-CLASS™ XLPE Liner is also compatible with previously cleared MicroPort Femoral Heads. Compatibility of the subject Liner with previously cleared MicroPort Orthopedics is listed in Table 1. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue rounded square with a white circle inside, containing a red star-like shape. To the right of the square is the word "MicroPort" in blue, with "Orthopedics" underneath in red. #### Table 1: Prime E-CLASS™ XLPE Liner Compatibility | 510(k) | Intended Combinations | |---------------------------------|--------------------------------------------------------| | with Femoral Heads (up to 44mm) | | | K893685 | Ceramic-Polyethylene with ID 28-36mm** | | K920593 | Ceramic-Polyethylene, OD 28mm | | K925512 | Ceramic-Polyethylene, OD 28mm | | K932222 | Metal-Polyethylene, OD 28mm XXL | | K002149 | Metal-Polyethylene with ID 22-32mm | | K021349* | Metal-Polyethylene with ID 38-56mm | | K004043* | Metal-Polyethylene with ID 28-36mm | | K051348* | Metal-Polyethylene with ID 38-56mm | | K072656 | Ceramic-Polyethylene with ID 38-46mm with neck sleeves | | K130376 | Ceramic-Polyethylene with ID 32-40mm | | K140043 | Ceramic-Polyethylene with ID 28mm | | with Acetabular Shells | | | K170444 | Quad and Solid Acetabular Shells | | K180798 | Quad and Solid Acetabular Shells | | with Instrumentation | | | K170444 | Acetabular Liner Trials | *Metal femoral heads in K021349, K004043 and K051348 were originally cleared for use with metal-metal bearings, and later cleared for compatibility with DYNASTY® A-CLASS® polyethylene liners in K070785. ** 36mm Forte Ceramic heads were originally cleared for use in PMA P030027, and later cleared for compatibility with PROCOTYL® L / O Acetabular System in K142119. #### H. Sterilization Residuals Ethylene Oxide sterilization of the subject Liner was evaluated per AAMI TIR 28:2009 Annex A. The evaluation determined that sterilization residuals are within the limits determined by the worst case, which was presented in K140043 as established by product density, product size, and worst case sterilization conditions. #### I. Conclusion The indications for use and fundamental scientific technology of the Prime E-CLASS™ XLPE Liner are identical to the predicate and reference devices. The subject Liner's geometry is identical to the predicate K180798. The subject Liner's material is identical to the predicate K171181. Additionally, the Prime E-CLASS™ XLPE Liner's compatibility with other components is identical to the predicate liners cleared within K171181 and K180798. The predicate and subject testing and analyses support the substantial equivalence of the Prime E-CLASS™ XLPE Liner's performance.