Bencox M Stem (Bencox 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

The Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug is intended for cemented use in total or partial hip arthroplasty and 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

The Centralizer is intended to be used with Bencox ID Cemented Stem to centralize the femoral stem within the intramedullary canal.

The Bencox Bone Plug is intended to be used with cemented hip replacement procedures to control and restrict the flow of cement within the intramedullary canal.

Device Description

Bencox M Stem (Bencox Hip System) - Sterile
The Bencox M Stem is a double tapered wedge shaped stem intended for press-fit partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Femoral Head and used with Bencox Acetabular Cups cleared under K103431, K112019, K120924. K121665 & K150007. When used in partial hip arthroplasty Bencox M Stem is coupled to a Femoral Head and used with Bencox Bipolar Cup cleared under K112019.

Bencox M Stem is made of Ti6AI4V alloy conforming to ASTM F136. The proximal half of the stem is plasma sprayed coating of pure titanium as per ASTM F1580. The materials used in subject device, Bencox M Stem, have been cleared for use in K112019 & K150007 for Bencox ID Stem & Bencox ID Stem (offset). The stem has a tapered rectangular section. The stem has a neck with a standard 12/14 conical taper to couple to Bencox Femoral Heads which have been cleared earlier. The Bencox M Stem is available 13 sizes with CCD angle of 132°. The stem is available in 13 sizes.

All the above described technological characteristics of subject device is similar to the identified predicate devices.

BENCOX ID Cemented Stem (with Centralizer) & Bone Plug - Sterile
Bencox ID Cemented Stem has bone plug and centralizer as accessories. The Collarless Bencox ID Cemented Stem consists of a polished double tapered distal geometry which generates the radial compressive load in distal body. The neck shape is similar to cleared Corentec's hip femoral stems in K103431, K122099 and K150007. The standard Morse taper (12/14) is used for femoral head assembly similar to cleared devices to couple to Bencox Femoral Heads and their compatible acetabular components which have been cleared in previous premarket notifications. The Bencox ID Cemented Stem is available 06 sizes with CCD angle of 132°. Bencox ID Cemented Stem is made of SS allov.

The deformable centralizer is made of PMMA with flexible wing like projections that extend outwards from the base of the centralizer and fits over the outside diameter of the stem tip. These projections contact the walls of the femoral canal, centralizing the hip stem within the canal. The hollow centralizer is designed to allow stem to engage distally within the cement mantle, subjecting the cement to compressive loading, and reducing end bearing of the stem directly onto the cement. The centralizer is a molded acrylic device manufactured from PMMA.

Bencox bone plug has a double flanged geometry very similar to the predicate devices. The plug blocks the propagation of the doughy bone cement downward in the medullary cavity. The proximal flange provides a proximal barrier, while the more flexible distal flange forms a secondary seal to prevent cement leakage. Bencox bone plug is manufactured from UHMWPE.

All the above described technological characteristics of subject device is similar to the identified predicate devices.

Accessory BENCOX Hip Instrumentation: (Non Sterile)
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 stainless steel and/or polymers and/or silicon which are cleared for use in previous premarket notifications of Corentec.

Bencox Hip System Instrumentation to be used Bencox M Stem (Bencox Hip System) & Bencox ID Cemented Stem is same with Instrumentation cleared under K103431, K112019, K120924 & K122099 along with the inclusion of instruments specific to Bencox M Stem such as Rasp, Impactor etc.

AI/ML Overview

The provided text is a 510(k) summary for the Bencox M Stem and Bencox ID Cemented Stem (with Centralizer) & Bone Plug. This document describes a medical device and its equivalence to previously approved predicate devices, primarily based on non-clinical performance data. It does not describe a study involving patient data, ground truth establishment, or clinical performance metrics in the way your request outlines for AI/software-based devices.

Therefore, for the specific questions related to acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, the information is not applicable or not available within this document because it pertains to a different type of device evaluation (hardware instead of software/AI).

However, I can extract the relevant performance data based on the non-clinical testing conducted for this orthopedic implant.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an orthopedic implant, the "acceptance criteria" and "reported device performance" are based on mechanical properties and material standards rather than diagnostic accuracy metrics. The document asserts that the device met these criteria through various tests, demonstrating substantial equivalence to predicate devices.

Acceptance Criteria (Implied by Standards)	Reported Device Performance
Mechanical strength and fatigue resistance for femoral stems (e.g., as per ISO 7206-4, ISO 7206-6, ISO 21535, ISO 7206-9, ISO 7206-10)	Testing showed the subject devices are expected to be safe and effective for proposed indications and substantially equivalent to predicate devices. (Specific quantitative results not provided in the summary).
Static pull-off strength	Conducted. Results support safety, effectiveness, and substantial equivalence.
Rotational torque testing	Conducted. Results support safety, effectiveness, and substantial equivalence.
Dynamic compression testing	Conducted. Results support safety, effectiveness, and substantial equivalence.
Corrosion resistance (for Ti6Al4V alloy, SS alloy)	Conducted using ASTM F1875. Results support safety, effectiveness, and substantial equivalence.
Range of motion testing	Conducted. Results support safety, effectiveness, and substantial equivalence.
Sterility Assurance Level (SAL) of 10^-6 (as per ISO 11137-1 & 2)	Sterilization validation confirms SAL of 10^-6.
Packaging stability and effectiveness for a 5-year shelf life (as per ASTM F1980)	Packaging subjected to sterile barrier testing & accelerated aging to validate a 5-year shelf life.
Material characteristics conforming to standards (e.g., Ti6Al4V alloy conforming to ASTM F136, pure titanium as per ASTM F1580, PMMA, UHMWPE)	Materials used conform to specified ASTM standards and are similar to predicate devices.
Biocompatibility	(Implied by the use of standard materials that have been cleared in previous devices, but no specific biocompatibility study details are provided in this summary. This type of testing is typically required for new materials or configurations.)

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not applicable in the context of diagnostic accuracy. For mechanical testing, "samples" would refer to the number of physical devices or components tested. This number is not specified in the 510(k) summary, but it would typically be a statistical minimum required by the testing standard.
Data Provenance: Not applicable for clinical data. The performance data is derived from in vitro mechanical testing conducted by the manufacturer, Corentec Co., Ltd., in South Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a physical implant, not a diagnostic AI/software. There is no "ground truth" derived from expert interpretation in the clinical diagnostic sense. The ground truth for mechanical properties is established by adherence to recognized engineering and material standards.

4. Adjudication method for the test set:

Not applicable. There is no expert adjudication for mechanical testing of this nature. Test results are compared against predefined acceptance criteria from international standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical orthopedic implant, not an AI/software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical orthopedic implant, not an AI/software.

7. The type of ground truth used:

Ground Truth Type: For orthopedic implants, the "ground truth" is defined by adherence to established engineering and material standards (e.g., ISO and ASTM standards for mechanical properties, material composition, and sterilization validation). The device's performance is compared against the requirements and benchmarks set by these standards, and against the equivalent performance of legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. This is a physical orthopedic implant. There is no "training set" in the context of machine learning. Design and manufacturing processes would be informed by engineering principles and historical data on similar devices, but not a "training set" in the requested sense.

9. How the ground truth for the training set was established:

Not applicable. As above, there is no training set. Design and manufacturing are based on established engineering principles and compliance with international standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of a human face in profile, with three overlapping faces.

April 29, 2016

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

Corentec Company, Limited J.S. Daniel Senior Manager/Engineer - RA & OA 8F Chungho Tower, 483, Gangnam-daero Seocho Gu, Seoul, 137-040 KOREA

Re: K152084

Trade/Device Name: BENCOX M Stem and Bencox ID Cemented Stem (with Centralizer) & Bone Plug 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, JDI, KWY, LZO Dated: March 28, 2016 Received: March 29, 2016

Dear J.S. 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 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

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(21 CFR Part 807); labeling (21 CFR Parts 801); medical device 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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 vours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Pq.1/1

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K152084

Device Name

Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug

Indications for Use (Describe)

Bencox M Stem (Bencox 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

The Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug is intended for cemented use in total or partial hip arthroplasty and 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

The Centralizer is intended to be used with Bencox ID Cemented Stem to centralize the femoral stem within the intramedullary canal.

The Bencox Bone Plug is intended to be used with cement procedures to control and restrict the flow of cement within the intramedullary canal.

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 M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bone Plug 25th April 2016

ADMINISTRATIVE INFORMATION

Manufacturer	Corentec Co., Ltd.
	12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu
	Cheonan-si, Chungchongnam-do, 331-822 South Korea
	Telephone: +82-41-585-7114
	Fax: +82-41-585-7113

Official Contact J.S. Daniel
Senior Manager/Engineer - RA/QA
Corentec Co., Ltd
8F Chungho Tower, 483, Gangnam-daero
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 M Stem (Bencox Hip System) & Bencox ID Cemented Stem (with Centralizer) and Bencox Bone Plug
Common Name:	Hip Prosthesis
Classification Regulations:	21 CFR 888.3358, 888.3390, 888.3350, 888.3353
Class:	Class II
Product Codes:	LPH, JDI, KWY, LZO
Classification Panel:	Orthopedic Products Panel
Reviewing Branch:	Orthopedic Devices Branch

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INTENDED USE

Bencox M Stem (Bencox Hip System)

Bencox M Stem (Bencox 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

BENCOX ID Cemented Stem (with Centralizer) & Bone Plug

The Bencox ID Cemented Stem (with Centralizer) & Bone Plug is intended for cemented use in total or partial hip arthroplasty and 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

The Centralizer is intended to be used with Bencox ID Cemented Stem to centralize the femoral stem within the intramedullary canal.

The Bencox Bone Plug is intended to be used with cemented hip replacement procedures to control and restrict the flow of cement within the intramedullary canal.

DEVICE DESCRIPTION

Bencox M Stem (Bencox Hip System) - Sterile

The Bencox M Stem is a double tapered wedge shaped stem intended for press-fit partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Femoral Head and used with Bencox Acetabular Cups cleared under K103431, K112019,

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K120924. K121665 & K150007. When used in partial hip arthroplasty Bencox M Stem is coupled to a Femoral Head and used with Bencox Bipolar Cup cleared under K112019.

All the above described technological characteristics of subject device is similar to the identified predicate devices.

BENCOX ID Cemented Stem (with Centralizer) & Bone Plug - Sterile

Bencox ID Cemented Stem has bone plug and centralizer as accessories. The Collarless Bencox ID Cemented Stem consists of a polished double tapered distal geometry which generates the radial compressive load in distal body. The neck shape is similar to cleared Corentec's hip femoral stems in K103431, K122099 and K150007. The standard Morse taper (12/14) is used for femoral head assembly similar to cleared devices to couple to Bencox Femoral Heads and their compatible acetabular components which have been cleared in previous premarket notifications. The Bencox ID Cemented Stem is available 06 sizes with CCD angle of 132°. Bencox ID Cemented Stem is made of SS allov.

All the above described technological characteristics of subject device is similar to the identified predicate devices.

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Accessory BENCOX Hip Instrumentation: (Non Sterile)

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 stainless steel and/or polymers and/or silicon which are cleared for use in previous premarket notifications of Corentec.

SUBSTANTIAL EQUIVALENCE

The subject devices are substantially equivalent in indications, design principles and technological characteristics to the following predicate devices, each of which has been determined by FDA to be substantially equivalent, as below,

SubjectDevices	Predicate Device/s
	PredicateCategory	Manufacturer	Trade Name	510(k)
BENCOX MSTEM	Primary	DePuy	TriLock	K010367
	Additional	Stryker	Allocade II	K103479 &K120578
BENCOXIDCementedSTEM (withCentralizer)	Primary	Stryker(Howmedica)	Exeter/Exeter V40 Stem	K803126;K011623; K110290
			Exeter Distal Centralizer	K974054
	Additional	DePuy	C Stem AMT Stem	K042959
			C Stem AMT DistalCentralizer	K042959 &K013350
BENCOXBONEPLUG	Primary	Smith &Nephew	Buck Cement Restrictor	K791125 (Referredin K023680)
	Additional	Zimmer	Allen Medullary Bone Plug	K001733

As described in the Device Description section, the technological characteristics, such as design, material, indications, and operating principles are similar to the identified predicate devices. The minor differences do not affect the safety and effectiveness of the device when used for the said indications, based on non clinical testing.

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PERFORMANCE DATA

The Bencox M Stem (Bencox Hip System) and BENCOX ID Cemented Stem was subjected to a series of testing protocols to document the performance of the components and to demonstrate substantial equivalence. Non-clinical testing and analysis included FEA, mechanical fatigue testing, and static pull off testing, rotational torque testing, dynamic compression testing, corrosion and range of motion testing.

The testing methods are described in the standards, ISO 7206-4. ISO 7206-6, ISO 21535, ISO 7206-9, ISO 7206-10, ASTM F2009, and ASTM F1875. The results of this testing showed that the subject devices are expected to be safe and effective for the proposed indications and are substantially equivalent to the predicate devices.

STERILIZATION

For all sterile implants, following to gamma sterilization, the packaging was subjected to sterile barrier testing to validate a shelf life of 5 years as per ISO & ASTM standards which confirms the stability and effectiveness of packaging of the sterilized product during the shelf-life, by evaluating changes by accelerated aging, as per ASTM F1980. Sterilization validation as per ISO 11137-1 & 2 Sterilization of health care products -Radiation ensures sterility of the components for an SAL of 10°.

All non sterile instruments used in the surgery must be sterilized by the hospital, prior to use, as mentioned in the instrument IFU.

Both Bencox M Stem (Bencox Hip System) and BENCOX ID Cemented Stem (with Centralizer) & Bone Plug have same shelf life of 5 years, similar to other cleared sterile devices of Corentec Co., Ltd.

CONCLUSION

Overall, the Bencox M Stem (Bencox Hip System) and BENCOX ID Cemented Stem (with Centralizer) & Bone Plug has similarities to the predicate devices with the same intended use, same fundamental scientific technology, similar design features, same operating principles, same materials and are supplied Sterile. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, material information and analysis of data in this PMN. Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy.

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.