(90 days)
Not Found
No
The document describes a mechanical hip implant system and its components. There is no mention of software, algorithms, image processing, AI, or ML. The performance studies are based on mechanical testing and biocompatibility, not algorithmic performance metrics.
Yes
The device is a hip acetabular system used in partial or total hip arthroplasty to treat various degenerative joint diseases and fractures, which are conditions that impair function and cause pain, and the device is intended to restore normal function and alleviate these issues."
No
Explanation: The device is an acetabular system used in hip arthroplasty, which is a medical procedure for treatment, not diagnosis. It is composed of an acetabular cup and a liner, designed for surgical implantation.
No
The device description clearly outlines physical components (Acetabular Cup and Acetabular Liner) made of materials like Titanium alloy and polyethylene, and the performance studies involve mechanical testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating various hip joint conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a hip replacement system (acetabular cup and liner). This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue) or providing information for diagnosis.
- Performance Studies: The performance studies focus on mechanical properties, wear, and biocompatibility, which are relevant to the function and safety of a surgical implant, not a diagnostic test.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a physical implant used in the body to treat a condition.
N/A
Intended Use / Indications for Use
Bencox Mirabo Cup System of Bencox Total Hip System is intended for Cementless use in partial or 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
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO
Device Description
The Bencox Mirabo Cup System is a Cementless hip acetabular system (Poly Liner) intended to be used with femoral components including either metal or ceramic heads and femoral stems to form a total hip system for hip arthroplasty. This submission consists of the following line extension components:
- Acetabular Cup Bencox Mirabo Cup
- . Acetabular Liner - Bencox Mirabo PE Liner
Acetabular Cup: Bencox Mirabo Cup
The Bencox Mirabo Cup Spec. Inclusion is similar to Bencox Mirabo Cup cleared under K162127 & K120924 with respect to material - Titanium alloy (ASTM F136), coating with pure Titanium powder (ASTM F1580), design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of acetabular cups with external diameter 50 mm.
Acetabular Liner: Bencox Mirabo PE Liner
The Bencox Mirabo PE Liner specification inclusion is similar to Bencox Mirabo PE Liner cleared under K162127 & K150007, with respect to material, conforming to ASTM F648, Type 2 (GUR 1050), and irradiated with average dose of 10.0 Mrad of gamma radiation, design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of Liner with head size, 28/42, 32/42, 36/42 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Wear Testing as per ISO 14242-1
- Liner Torsion as per ASTM F1820
- Pull out Testing as per ASTM F1820
- Push out Testing as per ASTM F1820
- Impingement as per ASTM F2582
- Cup deformation as per ISO 7206-12
- Acetabular cup fatigue as per ASTM F3090-20
- Range of Motion as per ISO21535
- Biocompatibility
Pyrogen testing was conducted in accordance with USP, USP, and ANSVAAMI ST72 to ensure the proposed BENCOX Mirabo Cup System 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
§ 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.
0
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May 18, 2022
Corentec Co.,Ltd. Yoorim Bae RA Manager 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu Cheonan-si, Chungcheongnam-do 31056 Republic of Korea
Re: K220468
Trade/Device Name: BENCOX Mirabo Cup System 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, LZO Dated: May 16, 2022 Received: May 16, 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
1
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 medical devices and radiation-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name BENCOX Mirabo Cup System
Indications for Use (Describe)
Bencox Mirabo Cup System of Bencox Total Hip System is intended for Cementless use in partial or 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)
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510(k) Summary
(As required by 21 CFR 807.92)
Date: February 15, 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: | Yoorim Bae |
| RA Manager | |
| 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu | |
| Cheonan-si, Chungcheongnam-do, Rep. of Korea -31056 | |
| Ph: +82-41-410-7116 (Direct) ; Fax: +82-41-585-7113 | |
| Email: yoorim.bae@corentec.com |
Device Information
| Trade or Proprietary Name: | BENCOX Mirabo Cup system |
|---|---|
| Common Name: | Acetabular Cup Prosthesis, Acetabular Liner Prosthesis |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated |
| uncemented prosthesis | |
| Class: | II |
| Classification panel: | 87 Orthopedics |
| Regulation: | 21CFR888.3358 |
| 21CFR888.3353 | |
| Product Code(s): | LPH, LZO |
Legally Marketed Device(s) to Which Equivalence is Claimed
| Predicate Devices | Manufacturer | 510(k) number | |
|---|---|---|---|
| Primary | |||
| Predicate | BENCOX Mirabo Cup System | Corentec Co.,Ltd | K120924 |
| Additional | |||
| Predicate | BENCOX Mirabo PE Liner | K150007 | |
| BENCOX Mirabo Cup Line extension | K162127 | ||
| K172806 | |||
| BENCOX Mirabo Cup Multi-hole | K182221 | ||
| ConforMIS BeneFIT Hip system | ConforMIS, Inc. | K190904 | |
| ZIMMER CONTINUUM ACETABULAR | |||
| SYSTEM, ZIMMER TRILOGY IT | |||
| ACETABULAR SYSTEM | ZIMMER, INC. | K091508 |
4
| E-XLPE Acetabular Components and U-
Motion II Acetabular Cup | United
Orthopedic
Corporation | K172833 |
| ----------------------------------------------------------------- | ------------------------------------- | --------- |
|---|
Reason for 510(k) Submission
The purpose of this submission is to include additional sizes for Cups and Liners to the previously cleared hip system.
Device Description
The Bencox Mirabo Cup System is a Cementless hip acetabular system (Poly Liner) intended to be used with femoral components including either metal or ceramic heads and femoral stems to form a total hip system for hip arthroplasty. This submission consists of the following line extension components:
- Acetabular Cup Bencox Mirabo Cup
- . Acetabular Liner - Bencox Mirabo PE Liner
Acetabular Cup: Bencox Mirabo Cup
The Bencox Mirabo Cup Spec. Inclusion is similar to Bencox Mirabo Cup cleared under K162127 & K120924 with respect to material - Titanium alloy (ASTM F136), coating with pure Titanium powder (ASTM F1580), design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of acetabular cups with external diameter 50 mm.
Acetabular Liner: Bencox Mirabo PE Liner
The Bencox Mirabo PE Liner specification inclusion is similar to Bencox Mirabo PE Liner cleared under K162127 & K150007, with respect to material, conforming to ASTM F648, Type 2 (GUR 1050), and irradiated with average dose of 10.0 Mrad of gamma radiation, design, locking system, manufacturing, packaging and sterilization. This submission is only for the inclusion of specification of Liner with head size, 28/42, 32/42, 36/42 mm.
Indications for Use
BENCOX Mirabo Cup System 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
The subject liners and acetabular shells are manufactured from the same materials and have the same locking mechanism and feature. The liners and shells are thinner than the previously cleared components. However, they are not thinner than the additional predicates.
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Non-Clinical Testing
This submission references mechanical testing results and engineering analysis for:
- . Wear Testing as per ISO 14242-1
- . Liner Torsion as per ASTM F1820
- . Pull out Testing as per ASTM F1820
- Push out Testing as per ASTM F1820 •
- Impingement as per ASTM F2582 •
- Cup deformation as per ISO 7206-12 •
- . Acetabular cup fatigue as per ASTM F3090-20
- · Range of Motion as per ISO21535
- . Biocompatibility
Pyrogen testing was conducted in accordance with USP, USP, and ANSVAAMI ST72 to ensure the proposed BENCOX Mirabo Cup System 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