BENCOX Mirabo Z Cup Cortinium

{0}------------------------------------------------ Image /page/0/Picture/0 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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. February 27, 2023 Corentec Co., Ltd. Songe Kang RA Associate 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu Cheonan-si, Chungcheongnam-do 31056 Republic of Korea Re: K223223 Trade/Device Name: BENCOX Mirabo Z Cup Cortinium 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: LPH Dated: February 21, 2023 Received: February 21, 2023 Dear Songe Kang: 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. {1}------------------------------------------------ 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) 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 (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 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. # Limin Sun -S Limin Sun, Ph.D. 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) #### K223223 Device Name BENCOX Mirabo Z Cup Cortinium Indications for Use (Describe) BENCOX Mirabo Z Cup Cortinium of BENCOX Total Hip System is intended for Cementless use in total hip arthroplasty in primary or revision surgery for the following conditions: a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis b. Inflammatory degenerative joint disease, such as rheumatoid arthritis c. Treatment of non-union, femoral neck fracture, and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques d. Patients with failed previous surgery where pain, deformity, or dysfunction persists e. Revision of previously failed total hip 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}------------------------------------------------ # 510(k) Summarv (As required by 21 CFR 807.92) Date: October 14, 2022 ## Administrative Information | Manufacturer: Corentec Co., Ltd. | |-----------------------------------------------------| | 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu | | Cheonan-si, Chungcheongnam-do, Rep. of Korea -31056 | | Telephone: +82-41-585-7114; Fax: +82-41-585-7113 | | Official Contact: Songe Kang | | RA Associate | | 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu | | Cheonan-si, Chungcheongnam-do, Rep. of Korea -31056 | | Ph: +82-41-410-7117 (Direct); Fax: +82-41-585-7113 | | Email: songe.kang@corentec.com | #### Device Information | Trade or Proprietary Name: | BENCOX Mirabo Z Cup Cortinium | |----------------------------|--------------------------------------------------------------------------------------------------------| | Common Name: | Acetabular Cup Prosthesis | | Classification Name: | Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated<br>Uncemented Prosthesis. (21CFR888.3358) | | Class: | II | | Product Code(s): | LPH | #### Predicate Devices | Primary predicate: BENCOX Mirabo Z cup Cortinium (K210614) | |-----------------------------------------------------------------------------------------| | Additional predicates: BENCOX Mirabo Cup System (K120924, K162127, K172806, K220468) | #### Reason for 510(K) Submission The purpose of this submission is to include an additional size 50mm diameter acetabular cup to the previously cleared hip system. #### Device Description The subject BENCOX Mirabo Z cup Cortinium shares key design features, materials, Indications for Use statements, geometry, and compatibility with other Corentec acetabular components marketed under the brand names BENCOX Mirabo Cup System and BENCOX Mirabo Z Cup Cortinium. The BENCOX Mirabo Z cup Cortinium is similar to the predicate devices BENCOX Mirabo Z Cup Cortinium cleared under K210614 and Bencox Mirabo Cups cleared under K220468, K172806, K162127, K120924 with respect to material - Titanium alloy (ASTM F136), and coated by pure titanium powder (ASTM F1580) through an additive manufacturing process, design, locking system, manufacturing (without coating processes), packaging and sterilization. This submission is only for the inclusion of specification of BENCOX Mirabo Z Cup Cortinium with external diameter 50mm. {4}------------------------------------------------ The manufacturing process including additive manufacturing is identical to the predicate. The subject 50mm acetabular shell is thinner than the predicate 50mm shells but it is not thinner than other sized shells in the predicate submission. Otherwise, the geometry of the features is identical to the predicate. The subject devices operate using the same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction, are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation to legally marketed device cleared under K120924, K162127, K172806, K220468 and K210614. ### Indications for Use BENCOX Mirabo Z Cup Cortinium of BENCOX Total Hip System is intended for cementless use in total hip arthroplasty in primary or revision surgery for the following conditions: a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis - b. Inflammatory degenerative joint disease, such as rheumatoid arthritis - c. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur - with head involvement, unmanageable using other techniques - d. Patients with failed previous surgery where pain, deformity, or dysfunction persists - e. Revision of previously failed total hip arthroplasty #### Summary of Technological Characteristics Device Comparisons and performance testing indicate that BENCOX Mirabo Z Cup Cortinium is substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles. #### Non-Clinical Testing The Corentec Co., Ltd. has evaluated the subject BENCOX Mirabo Z Cup Cortinium to demonstrate substantial equivalence to the predicate devices BENCOX Mirabo Z Cup Cortinium cleared under K210614 and Bencox Mirabo Cups cleared under K220468, K172806, K162127, K120924, and determined that the subject devices do not represent a new worst case. - . Wear Testing as per ISO 14242-1 and 14242-2 - . Cup Deformation as per ISO 7206-12 - . Shell Fatigue Testing as per ASTM F3090 - Impingement Testing as per ASTM F2582 • - Push out Testing as per ASTM F1820 • - . Lever out Testing as per ASTM F1820 - Offset Pull out Testing as per ASTM F1820 . - Torque out Testing as per ASTM F1820 - Range of Motion as per ISO 21535 . - Biocompatibility risk assessment and testing {5}------------------------------------------------ Pyrogen testing was conducted in accordance with USP<161>, USP<85>, and ANSI/AAMI ST72 to ensure the proposed BENCOX Mirabo Z Cup Cortinium meets recommended limits per FDA's Guidance Document submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile. Bacterial endotoxin testing (BET) as specified in ANSVAAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of < 20EU/Device. ## Substantial Equivalence Conclusion Based upon a comparison of intended use, materials, summary of technological characteristics, and non-clinical testing, the BENCOX Mirabo Z Cup Cortinium is substantially equivalent to the predicate devices identified in this premarket notification.