BENCOX Total Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:

· non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis;

· Inflammatory degenerative joint disease, such as rheumatoid arthritis;

· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques;

· patients with failed previous surgery where pain, deformity, or dysfunction persists;

· revision of previously failed total hip arthroplasty.

Device Description

The Additional components being added to the BENCOX THR System are:

Instrumentation (Head trial, Bencox Hybrid PE Liner Trial - STD/ELV, Bencox Mirabo PE Liner Trial - STD/ELV, Shell Trial, Bipolar Cup Trial, Bipolar Cup Trial Ring, Head Impacting Part, Liner Impacting Part)

The Bencox Hip Instrumentation is a set of accessories to be used with Bencox Hip Implants. The instruments are designed to be simple, conventional, and accurate and all parts of which are used for their respective procedures by qualified orthopedic surgeons. The parts of the instruments are made of Propylux and/or SUS along with colorants which are biocompatible and used in medical industry for decades and cleared for use in previous premarket notifications of Corentec.

The Trials are used to match the different anatomical structures of the hip joint and the Impacting Parts are used to combine the components together. These instruments are reusable devices that must be sterilized prior to use.

The trials and impacting parts of this submission are made of Propylux and/or SUS conforming to ASTM D4101: Standard Classification System and Basis for Specification for Polypropylene Injection and Extrusion Materials, and ASTM F899:

Standard Specification for Wrought Stainless Steels for Surgical Instruments, respectively.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the BENCOX THR System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the following information:

A table of acceptance criteria and reported device performance.
Sample size used for a test set or its data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for a test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
Information on standalone (algorithm-only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a test set.
Sample size for a training set.
How ground truth for a training set was established.

Explanation from the document:

The document states under "Non-Clinical Testing":
"The designs, dimensions and function of additional instruments are similar with predicate devices under K162127. Additional performance testing is unnecessary since the trial is not implanted."

And under "Clinical Testing":
"Clinical testing for BENCOX THR System Instrumentation were not required as a basis for substantial equivalence."

This explicitly indicates that no clinical performance studies, which would typically involve testing against acceptance criteria, were conducted or required for this 510(k) submission. The basis for clearance is the demonstrated substantial equivalence to predicate devices through technical characteristics and non-clinical engineering analysis (e.g., dimensions).

Summary

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July 14, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & 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.

Corentec Co., Ltd. Sungwon Yang ()mr 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu Cheonan-si, Chungchongnam-do 31056 Korea, South

Re: K211866

Trade/Device Name: BENCOX THR 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, KWY Dated: June 11, 2021 Received: June 16, 2021

Dear Sungwon Yang:

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

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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,

for

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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K211866

Device Name BENC0X THR System

Indications for Use (Describe)

BENCOX Total Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:

· non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis;

· Inflammatory degenerative joint disease, such as rheumatoid arthritis;

· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques;

· patients with failed previous surgery where pain, deformity, or dysf unction persists;

· revision of previously failed total hip arthroplasty.

Type of Use (Select one or both, as applicable)
☒ 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 THR System

June 11th, 2021

ADMINISTRATIVE INFORMATION

Manufacturer: Corentec Co., Ltd. 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu Cheonan-si, Chungchongnam-do, South Korea -31056 Telephone: +82-41-585-7114; Fax: +82-41-585-7113 Official Contact: Seungri Kim Associate - RA 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu Cheonan-si, Chungchongnam-do, Rep. of Korea -31056 Ph: +82-41-410-7117 (Direct) ; Fax: +82-41-585-7113 Email: sr.kim(@corentec.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	BENCOX THR System
Common Name:	Total Hip Joint Replacement Prosthesis
Classification Regulations:	21 CFR 888.3358, 888.3353, 888.3390
Class:	II
Product Codes:	LPH, LZO, KWY
Classification Panel:	Orthopedic Products Panel
Reviewing Branch:	Orthopedic Devices Branch

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INDICATIONS FOR USE

The Indications for Use of the added specification has not changed as a result of the modification of the predicate device cleared under BENCOX THR System, K112019 & K150007 & K162127.

BENCOX Total Hip System is intended for cementless use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:

· non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis;
· Inflammatory degenerative joint disease, such as rheumatoid arthritis;
· Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques;
· patients with failed previous surgery where pain, deformity, or dysfunction persists;
· revision of previously failed total hip arthroplasty.

DEVICE DESCRIPTION

The Additional components being added to the BENCOX THR System are:

Instrumentation (Head trial, Bencox Hybrid PE Liner Trial - STD/ELV, Bencox Mirabo PE Liner Trial - STD/ELV, Shell Trial, Bipolar Cup Trial, Bipolar Cup Trial Ring, Head Impacting Part, Liner Impacting Part)

Standard Specification for Wrought Stainless Steels for Surgical Instruments, respectively.

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Substantial Equivalence

BENCOX THR System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:

Substantially equivalent products for BENCOX THR System are as follows,

Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed:

510(k) Number	Trade orProprietaryModel Name	Manufacturer
K162127	Bencox M StemLat. Offset& Mirabo CupSystem	Corentec Co. Ltd

Reference Devices Supporting Substantial Equivalence:

510(k) Number	Trade orProprietaryModel Name	Manufacturer
K112019	BENCOX Bipolar Cup System	Corentec Co. Ltd
K150007	Modified BencoxMiraboHip System	Corentec Co. Ltd

Summary of Technological Characteristics:

BENCOX THR System additional instrumentations performed either similar comparable predicate devices and are as safe and effective as predicate device. Any differences in

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technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy. At a high level, BENCOX THR System has the following similarities to the predicate devices:

o has the same intended use,
o has the same indications for use,
o has the same operating principles,
has the same conditions of use,
o incorporates the same basic design
o has the similar size, and
o is supplied non-sterile

Non-Clinical Testing

The following non-clinical laboratory testing and/or engineering analysis were performed to determine substantial equivalence:

. Dimensions measurement testing
The designs, dimensions and function of additional instruments are similar with predicate devices under K162127. Additional performance testing is unnecessary since the trial is not implanted.

Clinical Testing

Clinical testing for BENCOX THR System Instrumentation were not required as a basis for substantial equivalence.

STERILIZATION & PACKAGING

BENCOX THR System Instrumentation are supplied non-sterile and cited predicate devices are non-sterile.

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CONCLUSION

Corentec Co., Ltd. believes that the subject devices are substantially equivalent to the legally marketed predicate device based on intended use, technology, geometry as well as the non-clinical testing.

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.