Prime BIOFOAM® Multi-Hole Shells

{0}------------------------------------------------ August 24, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. MicroPort Orthopedics Inc. Ryan Ross Manager - Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002 Re: K201157 Trade/Device Name: Prime BIOFOAM® Multi-Hole Shells Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBL, LPH, LZO Dated: August 11, 2021 Received: August 12, 2021 Dear Ryan Ross: 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/cdrh/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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201157 Device Name Prime BIOFOAM® Multi-Hole Shells #### Indications for Use (Describe) The Prime Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. 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® 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. 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/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a red star-like shape inside, followed by the text "MicroPort" in a larger, bolder blue font. Below "MicroPort" is the word "Orthopedics" in a smaller, lighter blue font. Prime BIOFOAM® Multi-Hole Shell Traditional 510(k) Tab 007: 510(k) Summary # 510(k) Summary Prime BIOFOAM® Multi-Hole Shell In accordance with 21 CFR 807.92 and the Safe Medical Devices Act of 1990, this information serves as a Summary of Substantial Equivalence for the Prime BIOFOAM® Multi-Hole Shell. The submission was prepared in accordance with FDA Guidance Document "Format for Traditional and Abbreviated 510(k)s", issued September 13, 2019. | Submitted by: | MicroPort Orthopedics Inc.<br>5677 Airline Road<br>Arlington, TN 38002<br>USA | | | |-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------------------------| | Date: | August 24, 2021 | | | | Contact Person: | Ryan Ross<br>Sr. Manager, Regulatory Affairs<br>Phone: (901) 867-4401<br>Fax: (901) 451-6018<br>Email: ryan.ross@ortho.microport.com | | | | Proprietary Name: | Prime BIOFOAM® Multi-Hole Shell | | | | Common Name: | Acetabular Shell | | | | Classification<br>Name and<br>Reference: | 21 CFR 888.3358<br>Hip joint metal/polymer/metal semi-constrained porous-coated uncemented<br>prosthesis - Class II | | | | | 21 CFR 888.3353<br>Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous<br>uncemented prosthesis - Class II | | | | Subject Panel and<br>Product Code(s): | Orthopedics/87/MBL, LPH, LZO | | | | Legally Marketed Devices to which Substantial Equivalence is claimed: | | | | | Primary Predicate: | K170444 | Prime Acetabular Cup System | MicroPort Orthopedics Inc. | | Predicate Devices: | K122382 | DYNASTY® BIOFOAM® Shell | MicroPort Orthopedics Inc. | DYNASTY® BIOFOAM® Shell K082924 MicroPort Orthopedics Inc. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a white circle inside, containing a red diamond shape. To the right of the square is the word "MicroPort" in blue, with the word "Orthopedics" in a smaller font size underneath. ### DEVICE INFORMATION ### A. Device Description MicroPort is introducing the Prime BIOFOAM® Multi-Hole Shells as a line extension of its existing Prime Acetabular System (K170444, K171181, K180798, and K181598). The subject implants are single use only, are provided sterile, and are to be implanted only by orthopedic specialists in an operating room setting. Associated instrumentation is reusable, provided nonsterile, and are to be used only by orthopedic specialists in an operating room setting. The Prime BIOFOAM® Multi-Hole Shell includes 10, 12, or 14 screw hole variations. The subject acetabular shells can be used with existing MicroPort devices listed in Section G, Table 3 to form a complete total hip system. - Multi-Hole Acetabular Shells - Material: Ti alloy conforming to ASTM F620 O - Coating: Commercially Pure Ti Foam conforming to ASTM F67 O (BIOFOAM®) - Outer diameters: 42mm to 68mm with 2 mm increments O - Variants: 10, 12, or 14 screw holes O - Sterilized using Gamma Radiation O ### B. Intended Use The Prime Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. #### 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® coating are intended only for uncemented arthroplasty. #### C. Summary of Technological Characteristics The design features and materials of the Prime BIOFOAM® Multi-Hole Shell are substantially equivalent to those of the predicate devices. The indications are identical to the predicate devices. The fundamental scientific technology of the subject devices has not change relative to the predicate devices. Sterilization methods are identical to the predicate devices. Different from the predicate acetabular shells, which have 3 screw holes, the subject acetabular shell has 10, 12, or 14 screw holes dependent on shell size. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo consists of a blue rounded square with a red star inside a white circle on the left. To the right of the icon is the text "MicroPort" in a larger, bold blue font, with "Orthopedics" underneath in a smaller, regular blue font. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis of data provided within this Premarket Notification. ## D. Nonclinical Testing Nonclinical bench testing was performed to evaluate and demonstrate the substantial equivalence of the subject Prime BIOFOAM® Multi-Hole Shells to their legally marketed predicate devices. - Frictional Torque/Pinch Load, per ISO 7206-2 and ISO 7206-12 ● - Finite Element Analysis, per ASTM F3090 ● - Long-Term Shell Fatigue, per ASTM F1820, ASTM F2068, and ASTM F3090 ● Predicate nonclinical test results were leveraged to support the subject device via equivalency rationale. - MR Conditionality Assessments (Field Interactions, Artifacts, RF Heating), per ● ASTM F2052, ASTM F2119, ASTM F2503, ASTM F2182 ## E. Clinical Testing Clinical testing was not provided for the subject devices. ## F. Biocompatibility The intended patient contact and materials used in the subject implant devices are identical to the predicate devices. All subject instruments have identical patient contact and materials as instrumentation cleared as part of K170444. ## G. Instrumentation The Prime BIOFOAM® Multi-Hole Shell uses existing instrumentation submitted as part of K170444. No new instrumentation is being introduced for the subject device. ## H. Conclusion Based on the intended use, indications for use, design features, the use of established wellknown materials, and results of the nonclinical bench testing, the subject Prime BIOFOAM® Multi-Hole Shell is substantially equivalent to the legally marketed devices listed in this summary.