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

Device Description

The COREN Total Hip System is a cementless, metal-on-polyethylene hip system for hip arthroplasty. It consists of the following components: Femoral stem - Modified BL Coren Stem; Femoral head - Coren Metal Head; Acetabular system - Coren U Cup, Coren PE Insert and Coren Bone Screw; and Coren THR Instrumentation. The components are manufactured from the following materials: Ti-6A1-4V 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 Allovs for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539); and ultra-high molecular weight polyethylene conforming to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants. COREN Total Hip System components are sterilized by gamma irradiation or ethylene oxide.

AI/ML Overview

This 510(k) summary for the COREN® Total Hip System does not contain the acceptance criteria or a study demonstrating the device meets such criteria in the way typically expected for an AI/ML powered device.

Instead, this document describes a traditional medical device (a total hip system) and focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through material comparisons, design similarities, and performance testing against recognized standards.

Here's a breakdown based on your requested information, highlighting where the information is present and where it is not applicable or unavailable in this type of submission:

Acceptance Criteria and Device Performance for COREN® Total Hip System

Given this is a 510(k) submission for a traditional implantable medical device (Total Hip System) and not an AI/ML powered device, the concept of "acceptance criteria" and "device performance" in the context of sensitivity, specificity, accuracy, etc., as one would expect for an AI algorithm's diagnostic or predictive capabilities, is not applicable here.

Instead, acceptance criteria relate to meeting specific engineering and materials standards to ensure safety and effectiveness comparable to predicate devices. The "performance" is demonstrated through adherence to these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Standards Applied)	Reported Device Performance (Summary from Submission)
Material Specifications: Adherence to ASTM F136 (Ti-6A1-4V ELI), ASTM F1537 (Co-Cr-Mo alloy), ASTM F648 (UHMWPE)	Components manufactured from specified materials: Ti-6A1-4V alloy, Co-Cr-Mo alloy, and ultra-high molecular weight polyethylene, all conforming to respective ASTM standards.
Mechanical Performance Standards (Examples): - ISO 7206-4 (Fatigue test for stemmed femoral components)- ISO 7206-8 (Endurance performance of stemmed femoral components)- ASTM F543 (Test methods for metallic medical bone screws)- ISO 14242-1, ISO 14242-2 (Wear of hip joint prostheses)- ASTM F1820 (Porosity of coatings)- ISO 7206-10 (Static and dynamic tests of UHMWPE inserts)- ISO 7206-9 (Endurance performance of acetabular components)- ISO 7206-2 (Static and dynamic tests of acetabular components)- ASTM D638 (Tensile properties of plastics)- ASTM F2183 (Test method for assessing attachment of porous coatings)- ASTM F2214 (Pore size distribution)- ASTM F2381 (Hydrodynamic wear of total hip prostheses)- ASTM F1160 (Shear testing)- ASTM F1044 (Scratch hardness)- ASTM F1147 (Fatigue testing)- ASTM F1978 (Test method for measuring attachment strength)- ASTM F2582 (Oxidation of UHMWPE)	Performance testing was conducted to demonstrate substantial equivalence and included methods described in the numerous listed ISO and ASTM standards. Specific results are not detailed but the FDA's clearance implies these standards were met. - Attachment strength between UHMWPE liner and acetabular shell was tested by measuring torque out and lever out strengths. - Residual free radical content in crosslinked UHMWPE was assessed by electron spin resonance (ESR).
Biocompatibility/Sterilization: ISO 10993-7 (Ethylene oxide sterilization residuals)	Device components are sterilized by gamma irradiation or ethylene oxide. Implied compliance with ISO 10993-7 for ETO sterilization.
Design Principles: Similarities in geometry, sizes, surface finishes, neck angles, porous coatings, internal taper mechanisms, modularity.	The submission details extensive similarities in design principles, materials, manufacturing processes, and component features (e.g., grit-blasted surface finish, neck angles, plasma-sprayed porous coatings, UHMWPE cross-linked material, tapered interfaces) to several predicate devices.

Summary of the Study:

The study proving the device meets the acceptance criteria is a series of engineering and materials performance tests conducted in accordance with a comprehensive list of international and national standards relevant to orthopedic implants. This type of submission relies on demonstrating that the new device performs at least as well as, and is as safe and effective as, legally marketed predicate devices by conforming to established engineering and material specifications.

Detailed Responses to Specific Questions:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated as a "sample size" in the context of patient data. The "sample size" here refers to the number of test articles (implants, materials) subjected to various engineering and mechanical tests. The specific number of test articles for each standard would be defined by the standard itself or the internal test protocols, but it's not detailed in the 510(k) summary.
Data Provenance: The tests are laboratory-based engineering and material tests, not clinical data from patients. The data would originate from Corentec Co., Ltd. or its contracted testing laboratories, likely in South Korea or other countries where such testing houses are located. These are prospective tests performed on newly manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device submission. No "ground truth" based on expert clinical assessment (like radiologists) is established here. The "ground truth" is defined by the technical specifications and performance limits set by the international and national standards (e.g., ISO, ASTM). The "experts" involved would be engineers, materials scientists, and quality assurance personnel performing and interpreting the results of these technical tests against the defined standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation where human experts evaluate patient data to establish a consensus "ground truth." For engineering performance testing, conformance to the specified standard is objectively measured and evaluated.

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

This question is not applicable. MRMC studies are relevant for AI/ML-driven diagnostic or image analysis tools that assist human readers. This device is a physical orthopedic implant.

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

This question is not applicable. This device is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is adherence to established engineering, material, and biocompatibility standards (e.g., ISO 7206 series, ASTM F136, ASTM F1537, ASTM F648, ASTM F10993 series). The device's performance is compared against the requirements and specifications within these standards and against the characteristics of the predicate devices.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical implant. The design of the COREN® Total Hip System would have been informed by established orthopedic design principles, clinical experience with similar implants (predicate devices), and engineering knowledge, rather than a data training set.

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

This question is not applicable as there is no training set for an AI/ML algorithm. The "ground truth" for the design and manufacturing of the hip system is based on the long-standing understanding of orthopedic biomechanics, material science, clinical outcomes of existing hip implants, and the regulatory requirements outlined in the various ISO and ASTM standards.

Summary

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510(k) Summary

JUL 2 1 2011

Corentec Co., Ltd.

COREN® Total Hip System

K103431

July 14, 2011

ADMINISTRATIVE INFORMATION

Manufacturer Name: Corentec Co., Ltd. 247 Giro-ri, Ipjang-myeon, Seobuk-Gu Cheonan-si, Chungchongnam-do, 331-822 South Korea Telephone: +82-41-585-7114 +82-41-585-7113 Fax: Official Contact: J.S. Daniel Project Manager - QA/RA 11th Chungho Tower, 748-1 Banpo-1 Dong, Seocho Gu, Seoul, South Korea, 137-040 Telephone: +82-2-3445-5475 Fax: +82-2-3445-5497 Email: isdaniel@corentec.com Kevin A. Thomas, PhD Representative/Consultant: Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: kthomas@paxmed.com

flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	COREN® Total Hip System
Common Name:	Total Hip Prosthesis System
Classification Regulation:	21 CFR 888.3358, Class II
Product Codes:	LPH
Classification Panel:	Orthopedic Products Panel
Reviewing Branch:	Orthopedic Devices Branch

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510(k) Summary

INTENDED USE

The COREN® Total Hip System is intended for use in total or partial hip arthroplasty and in primary or revision surgery for the following conditions:

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

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICES

Corentec Co., Ltd., submits the following information in this Premarket Notification to demonstrate that for the purposes of FDA's regulation of medical devices, the COREN® Total Hip 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:

Zimmer Austin, Inc., CLSTM Spotorno™ Stem, cleared under K042249;

Sulzer Orthopedics, Inc., CLS Varus/CLS 135 Stem, cleared under K010839;

Aesculap, Inc., Excia Total Hip System, cleared under K042344;

Wright Medical Technology, Inc., LINEAGE® A-CLASS™ Poly Liner, cleared under K052026:

Biomet, Inc., Metal on Metal Acetabular System, cleared under K993438; and

Biomet, Inc., M2a™ 32 mm Taper System, cleared under K003363.

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510(k) Summary

K103431

The COREN Total Hip System Modified BL Coren Stem and the CLS™ Spotorno™ Stem (K042249) and the CLS Varus/CLS 135 Stem (K010839) are made of the same material, have the same grit-blasted surface finish, have the same neck angle and have similar overall geometries and ranges of sizes.

The COREN Total Hip System Coren U Cup and the Excia Total Hip System (K042344) are both hemispherical acetabular cup made of the same material and both have plasma-sprayed porous coatings with similar pore size, porosity and coating thickness. The subject and predicate acetabular cups also incorporate holes through the cup in similar positions and angulations for optional screw fixation, and both an internal taper mechanism for locking the UHMWPE insert to the cup.

The COREN Total Hip System and the LINEAGE® A-CLASS™ Poly Liner (K052026) both include UHMWPE inserts made of the same cross-linked material, encompassing a similar range of configurations, and both incorporate a taper mechanism for locking to the acetabular cup.

The COREN Total Hip System Coren Metal Head and the Metal Acetabular System (K993438) and M2a™ 32 mm Taper System (K003363) all include modular femoral heads made of the same material and a similar tapered interface to the femoral stem. The subject and predicate modular femoral heads all encompass a similar range of head sizes, neck lengths and femoral offsets, and all have similar surface finish and sphericity.

Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy.

Performance testing was conducted to demonstrate substantial equivalence and included methods described in the following standards: ISO 7206-4, ISO 7206-8, ASTM F543, ISO 14242-1, ISO 14242-2, ASTM F1820, ISO 7206-10, ISO 7206-9, ISO 7206-2, ASTM D638, ASTM F2183, ASTM F648, ASTM D3418, ASTM F2214, ASTM F2102, ASTM F2381, ASTM F1160, ASTM F1044, ASTM F1147, ASTM F1978, ASTM F2582, ISO 7206-6, and ISO 10993-7. The attachment strength between the UHMWPE liner and the acetabular shell was tested by measuring torque out and lever out strengths. Residual free radical content in crosslinked UHMWPE was assessed by electron spin resonance (ESR).

Overall, the COREN Total Hip System has the following similarities to the predicate devices:

has the same intended use, .
uses the same operating principles, .
incorporates the same basic designs, .
incorporates the same or very similar materials, and .
has similar packaging and is sterilized using the same materials and processes. .

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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 caduceus, which is a symbol of medicine, with three lines representing the branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

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

Corentec Co. Ltd % Kevin Thomas, PhD Vice President and Director of Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

JUL 2 1 2011

Re: K103431

Trade/Device Name: COREN® Total Hip 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 Dated: June 15, 2011 Received: June 16, 2011

Dear Dr. Thomas:

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 (21

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Page 2 - Kevin Thomas, PhD

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Emil Keith

for 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

K103431 510(k) Number:

Device Name: COREN® Total Hip System

Indications for Use:

The COREN® Total Hip System is intended for use in total or partial hip arthroplasty and in primary or revision surgery for the following conditions:

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

Prescription Use __ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Page 1 of __

for m mcleerson

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

510(k) Number K103431

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.