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

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.

AI/ML Overview

This FDA 510(k) submission for the BENCOX Mirabo Cup System is for a medical device (hip joint prosthesis components), not an AI/ML software. Therefore, the information typically requested regarding acceptance criteria and studies for AI/ML performance (such as test set sample sizes, data provenance, expert ground truth, MRMC studies, or training set details) is not applicable to this document.

The document discusses mechanical testing and biocompatibility studies, which are relevant to the safety and effectiveness of a physical medical implant. Here's a summary of the non-clinical testing referenced for this device, which serves as the "study that proves the device meets the acceptance criteria" for a physical implant:

Acceptance Criteria and Reported Device Performance (Non-Clinical Testing for Physical Device)

Acceptance Criteria (Test Standard / Requirement Implied)	Reported Device Performance (Compliance)
Wear Testing (as per ISO 14242-1)	Referenced (implies compliance)
Liner Torsion (as per ASTM F1820)	Referenced (implies compliance)
Pull out Testing (as per ASTM F1820)	Referenced (implies compliance)
Push out Testing (as per ASTM F1820)	Referenced (implies compliance)
Impingement (as per ASTM F2582)	Referenced (implies compliance)
Cup deformation (as per ISO 7206-12)	Referenced (implies compliance)
Acetabular cup fatigue (as per ASTM F3090-20)	Referenced (implies compliance)
Range of Motion (as per ISO21535)	Referenced (implies compliance)
Biocompatibility	Referenced (implies compliance)
Pyrogen testing (in accordance with USP<161>, USP<85>, and ANSI/AAMI ST72)	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 ANSI/AAMI ST72:2011)	Achieves an Endotoxin limit of < 20EU/Device.

Information Not Applicable or Available in the Provided Document (as it pertains to AI/ML devices):

The following points are not applicable to this 510(k) submission because it concerns a physical orthopaedic implant, not an AI/ML software device. Information relevant to AI/ML performance would not be found in this type of submission.

Sample sizes used for the test set and data provenance
Number of experts used to establish ground truth
Qualifications of experts
Adjudication method for the test set
Multi-reader multi-case (MRMC) comparative effectiveness study
Stand-alone (algorithm only) performance
Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Sample size for the training set
How the ground truth for the training set was established

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K220468

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)

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) 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-GuCheonan-si, Chungcheongnam-do, Rep. of Korea -31056Telephone: +82-41-585-7114; Fax: +82-41-585-7113
Official Contact:	Yoorim BaeRA Manager12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-GuCheonan-si, Chungcheongnam-do, Rep. of Korea -31056Ph: +82-41-410-7116 (Direct) ; Fax: +82-41-585-7113Email: 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-coateduncemented prosthesis
Class:	II
Classification panel:	87 Orthopedics
Regulation:	21CFR888.335821CFR888.3353
Product Code(s):	LPH, LZO

Legally Marketed Device(s) to Which Equivalence is Claimed

Predicate Devices		Manufacturer	510(k) number
PrimaryPredicate	BENCOX Mirabo Cup System	Corentec Co.,Ltd	K120924
AdditionalPredicate	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 ACETABULARSYSTEM, ZIMMER TRILOGY ITACETABULAR SYSTEM	ZIMMER, INC.	K091508

{4}------------------------------------------------

E-XLPE Acetabular Components and U-Motion II Acetabular Cup	UnitedOrthopedicCorporation	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

Acetabular Cup Bencox Mirabo Cup
. Acetabular Liner - Bencox Mirabo PE Liner

Acetabular Cup: Bencox Mirabo Cup

Acetabular Liner: Bencox Mirabo PE Liner

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.

{5}------------------------------------------------

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<161>, USP<85>, 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 < 20EU/Device.

Substantial Equivalence Conclusion

Based upon a comparison of intended use, materials, summary of technological characteristics, and preclinical testing, the BENCOX Mirabo Cup System is substantially equivalent to the predicate devices identified in this premarket notification.

Regulation Number and Section

§ 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.