(449 days)
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
The BENCOX Mirabo Z Cup Cortinium is a porous coated non hemispherical outer shell made of Ti-6Al-4V alloy (ASTM F136) via machining processes and coated by pure titanium powder (ASTM F1580) through an additive manufacturing process. The device design allows for the cementless use of cross-linked polyethylene liners into the shell and incorporates screw holes for fixation.
The provided text is a 510(k) premarket notification for the BENCOX Mirabo Z Cup Cortinium. It describes the device, its intended use, and claims substantial equivalence to previously marketed predicate devices. However, it does not contain information about acceptance criteria, detailed study results proving a device meets acceptance criteria, sample sizes for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.
This document focuses on regulatory compliance through substantial equivalence, primarily based on design and material similarities, and a set of non-clinical bench tests comparing the device to existing standards and predicate devices.
Therefore, I cannot fulfill your request for this specific information based on the provided text. The document states "Device Comparisons and performance testing indicate that the BENCOX Mirabo Z Cup Cortinium is substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles," and lists the nonclinical testing performed (e.g., Cup Fatigue Testing per ASTM F3090-20, Porous Structure Characterization per various ASTM and DIN EN ISO standards). These tests are typically performed to demonstrate that the device meets existing standards and is comparable to previously cleared devices, rather than establishing specific acceptance criteria and proving performance against them in a clinical study format.
In summary, the provided document does not contain the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a clinical performance study.
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May 24, 2022
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Corentec Co.,Ltd. Yoorim Bae RA specialist 12, Yeongsanhong 1-gil, Ipjang-myeon, Seobuk-gu Cheonan-si, Chungcheongnam-do 31056 Republic of Korea
Re: K210614
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: May 18, 2022 Received: May 18, 2022
Dear Yoorim Bae:
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
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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,
Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K210614
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.
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510(k) SUMMARY Corentec Co., Ltd.
BENCOX Mirabo Z Cup Cortinium of BENCOX Total Hip System May 24, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer: | Corentec Co., Ltd.12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-GuCheonan-si, Chungchongnam-do, Rep. of Korea -31056Telephone: +82-41-585-7114; Fax: +82-41-585-7113 |
|---|---|
| Official Contact: | Yoorim BaeRA Specialist12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-GuCheonan-si, Chungchongnam-do, Rep. of Korea -31056Ph: +82-41-410-7116(Direct); Fax: +82-41-585-7113Email: yoorim.bae@corentec.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | BENCOX Mirabo Z Cup Cortinium |
|---|---|
| Common Name: | Acetabular Cup Prosthesis |
| Classification Regulations: | 21 CFR 888.3358Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis. |
| Regulatory Class: | Class II |
| Product Codes: | LPH |
| Classification Panel: | Orthopedic Products Panel |
Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed: Primary predicate:
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K120924 | BENCOX Mirabo Cup System | Corentec Co.,Ltd. |
Additional Predicates Supporting Substantial Equivalence:
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K000306 &K093646 | Pinnacle Acetabular System with ALTRX Liner | DePuy Orthopaedics,Inc. |
| K150790 | REDAPT Porous Acetabular Shell and CementedLiner | Smith & Nephew Inc. |
| K061253, K070756 | REFLECTION 3 ACETABULAR SYSTEM | Smith & Nephew Inc. |
| K182502 | Exactech® Alteon® Acetabular Cup System | Exactech, Inc. |
| K162127 | BENCOX Mirabo Cup Line extension | Corentec Co.,Ltd. |
| K172806 | BENCOX Mirabo Cup Line extension | Corentec Co.,Ltd. |
| K182221 | BENCOX Mirabo Cup Multi hole | Corentec Co.,Ltd. |
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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
DEVICE DESCRIPTION
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.
The BENCOX Mirabo Z Cup Cortinium is a porous coated non hemispherical outer shell made of Ti-6Al-4V alloy (ASTM F136) via machining processes and coated by pure titanium powder (ASTM F1580) through an additive manufacturing process. The device design allows for the cementless use of cross-linked polyethylene liners into the shell and incorporates screw holes for fixation.
The subject devices operate using the same fundamental scientific technology, have the same intended use and design features, employ the same materials of constructions, 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, and K18221. The only modifications subject by this submission are the titanium porous coating process of acetabular shell.
SUMMARY of TECHNOLOGICAL CHARACTERISTICS
Device Comparisons and performance testing indicate that the BENCOX Mirabo Z Cup Cortinium is substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles.
NONCLINICAL TESTING DESCRIPTION
Nonclinical bench testing was performed to evaluate and demonstrate the substantial equivalence of the subject BENCOX Mirabo Z Cup Cortinium to its legally marketed predicate devices.
- Cup Fatigue Testing per ASTM F3090-20 .
- Cup Deformation Testing per ISO 7206-12 •
- Porous Structure Characterization (Composition, Trace element, Microstructure, Mean void . intercept length, Porosity, Shear mechanical properties, Tensile mechanical properties, Abrasion resistance, Roughness) per ASTM E112, ASTM F1854, DIN EN ISO 25178. ASTM F1147, ASTM F1044, ASTM F1160, ASTM F1978
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Predicate nonclinical test results were leveraged to support the subject device via engineering analysis/ justification.
- Axial Pushout, Offset Pullout, and Torque-out per ASTM F1820 •
- . Impingement per ASTM F2582
- ・ Range of Motion (ROM) per ISO21535
- . Wear testing per ISO 14242-1
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.
BIOCOMPATIBILITY
The intended patient contact and materials used in the subject implant devices are identical to the predicate devices (K120924).
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.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.