The Bencox Hip System is intended for cementless use in total or partial 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

Bencox II Stem cleared under K103431 is modified at the proximal neck region. The other aspects of design / material / specification / manufacturing & sterilization / packaging are not altered and remain the same as discussed in K103431. The component is manufactured from Ti-6Al-4V alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401); Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants.

Bencox Metal Head is cleared under K103431 & K112019 with the neck lengths of small, medium and large. This submission includes extra large (XL) neck length as an inclusion to the existing specification. The other aspects of design / material / specification / manufacturing & sterilization/packaging are not altered and remain the same as discussed in K103431 & K112019. The component is manufactured from Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the Bencox II Stem & Bencox Metal Head, based on the provided text:

Important Note: This document describes a modification to an existing medical device (hip prosthesis components). The acceptance criteria and performance data provided relate to demonstrating that the modified device performs similarly or better than the previously cleared predicate devices, particularly regarding fatigue strength and range of motion. This is a common approach for 510(k) submissions for device modifications, focusing on demonstrating equivalence rather than establishing de novo clinical performance benchmarks.

Acceptance Criteria and Study Details for Bencox II Stem & Bencox Metal Head (K122099)

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not specify explicit numerical acceptance criteria in the typical sense for a diagnostic device (e.g., accuracy thresholds). Instead, for this orthopedic implant modification, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices through performance testing. The reported performance is comparative.

Acceptance Criterion (Implicit)	Reported Device Performance
Fatigue Strength: Must be equivalent or superior to predicate devices.	The Bencox II Stem neck change and Bencox Metal Head-XL components performed either similar or better than the predicate devices cleared under K103431 & K112019 when subjected to testing protocols for fatigue strength as described in ISO 7206-4 and ISO 7206-6.
Range of Motion: Must be equivalent or superior to predicate devices.	The Bencox II Stem neck change and Bencox Metal Head-XL components performed either similar or better than the predicate devices cleared under K103431 & K112019 when subjected to testing protocols for range of motion as described in ISO 21535.
Sterility Assurance Level (SAL): Components must be sterilizable to an SAL of 10^-6.	Sterilization validation as per ISO 11137 - 1 & 2 (Radiation) ensures sterility of the components for an SAL of 10^-6. This is consistent with the predicate devices.
Shelf Life for Sterility: Packaging must maintain sterility for a specified shelf life.	Packaging was subjected to sterile barrier testing to validate a shelf life of 5 years for both components. This is consistent with the predicate devices.
Biocompatibility/Material Safety: Materials must conform to recognized standards (implicit for substantial equivalence).	The components are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and Co-Cr-Mo alloy conforming to ASTM F1537, which are standard materials for surgical implants and are the same as used in the predicate devices. This implies continued meeting of biocompatibility standards.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify exact sample sizes for the mechanical and sterilization tests, but refers to "a series of testing protocols." For such device modifications, testing typically involves a sufficient number of samples to statistically demonstrate compliance with standards and equivalence, but specific numbers are not provided.
Data Provenance: The data is generated from laboratory testing (mechanical, sterilization, packaging) of the modified Bencox II Stem & Bencox Metal Head and comparison with the predicate devices. This is not patient-derived data. The manufacturing country is South Korea (Corentec Co., Ltd.). The data is prospective, generated specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable: For this type of submission involving mechanical and sterilization testing of an orthopedic implant component, "ground truth" is established by adherence to recognized international standards (ISO, ASTM) and established engineering principles, rather than expert clinical consensus on patient data. There is no mention of clinical experts being involved in establishing "ground truth" for these specific performance tests.

4. Adjudication Method for the Test Set:

Not Applicable: As the "test set" consists of physical devices undergoing laboratory performance testing against engineering standards, there is no need for an adjudication method involving multiple human readers/experts. The tests produce quantifiable results compared to standard requirements and predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, not done. This 510(k) submission pertains to physical modifications of an orthopedic implant system and its mechanical and sterilization performance, not a diagnostic device requiring human-in-the-loop performance evaluation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, not done. This product is a physical hip prosthesis component, not an algorithm or AI software. Therefore, an "algorithm only" performance study is not applicable.

7. Type of Ground Truth Used:

Engineering Standards and Predicate Device Performance: The "ground truth" for the performance evaluation is based on established international engineering standards for orthopedic implants (ISO 7206-4, ISO 7206-6, ISO 21535, ISO 11137-1 & 2) and the demonstrated performance of the previously cleared predicate devices (K103431 & K112019). The goal is to demonstrate that the modified device meets or exceeds these established benchmarks.

8. Sample Size for the Training Set:

Not Applicable: As this is a physical medical device (hip prosthesis components) and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by established engineering principles and prior device designs, but not through data-driven 'training' in the AI sense.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable: As there is no "training set" for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The performance evaluation is based on direct physical testing and comparison to engineering standards and predicate device performance.

Summary

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Special 510(k): Device Modification

K12209

510(K) SUMMARY

Corentec Co., Ltd.

ОСТ 5 2012

Bencox II Stem & Bencox Metal Head

July 10th, 2012

ADMINISTRATIVE INFORMATION

Manufacturer Corentec Co., Ltd. 247 Giro-ri, Ipjang-myeon, Seobuk-Gu Cheonan-si, Chungchongnam-do, 331-822 South Korea Telephone: +82-41-585-7114 Fax: +82-41-585-7113

J.S. Daniel Official Contact Project Manager - RA/QA Corentec Co., Ltd 8th Chungho Tower, 748-1 Banpo I Dong Seocho Gu, Seoul, Korea 137-040 Ph: +82 70 4393 3819 Fax: +82 2 3445 5467 Email: jsdaniel@corentec.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Bencox II Stem & Bencox Metal Head
Common Name:	Hip Prosthesis
Classification Regulations:	21 CFR 888.3358; 888.3390
Class:	II
Product Codes:	LPH; KWY
Classification Panel:	Orthopedic Products Panel
Reviewing Branch:	Orthopedic Devices Branch

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Special 510(k): Device Modification

Bencox II Stem & Bencox Metal Head

INTENDED USE

The Bencox Hip System is intended for cementless use in total or partial 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

DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The Bencox II Stem & Bencox Metal Head are substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent, as below,

. Corentec Co., Ltd., Coren Total Hip System (now renamed as Bencox Total Hip System) cleared under K103431
Corentec Co., Ltd., Bencox Bipolar Cup System cleared under K112019 .

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Bencox II Stem & Bencox Metal Head

PERFORMANCE DATA

The Bencox II Stem neck change & Bencox Metal Head components were subjected to a series of testing protocols to document the performance of the components and to demonstrate substantial equivalence for fatigue strength and range of motion and the included methods are described in the standards, ISO 7206-4, ISO 7206-6 & ISO 21535.

The Bencox Metal Head-XL was also tested with Bencox ID Stem (machined) & Bencox ID Stem (forged). Bencox 11 Stem neck change & Bencox Metal Head-XL components performed either similar or better than the predicate devices cleared under K103431 & K112019.

STERILIZATION & PACKAGING

Sterilization validation as per ISO 11137 - 1 & 2 Sterilization of health care products - Radiation ensures sterility of the components for an SAL of 106. Both Bencox Il Stem & Bencox Metal Head and the predicate devices cleared under K103431 & K112019 have same shelf life. Following sterilization, packaging was subjected to sterile barrier testing to validate a shelf life of 5 years for both components.

Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy. Overall, the Bencox II Stem neck change & Bencox Metal Head-XL has similarities to the predicate devices with the same intended use, same fundamental scientific technology, same operating principles, same materials and are supplied Sterile.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Corentec Company, Limited % Mr. J.S. Daniel Project Manager - QA/RA 11th Chungho Tower, 748-1 Banpo 1 Dong Seocho Gu, Seoul, Korea 137-040

OCT 5 2012

Re: K122099

Trade/Device Name: Bencox II Stem & Bencox Metal Head Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint metal/polymer/meta1 semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH; KWY Dated: September 4, 2012 Received: September 6, 2012

Dear Mr. Daniel:

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. 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

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Page 2 - Mr. J.S. Daniel

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erine l. Keith

-> Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K122099

Device Name: Bencox II Stem & Bencox Metal Head

The Bencox Hip System is intended for cementless use in total or partial 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

Prescription Use: X (Per 21 CFR 801 Subpart D)

AND / OR

Over-The Counter Use :-(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

AS~b

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122099

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.