The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

Device Description

U2 Cemented Femoral Component-CR Type is manufactured from cast Co-Cr-Mo alloy confirming to ASTM F75. It is available in seven proportional sizes (#1~ #7, AP/ML ranging from 52mm/ 56mm to 76mm/ 80mm) and is provided in left and right configurations. The femoral component is the same as that of cleared U2 Total Knee System (K051640), except adding size #7. Fixation of the femoral component to the femur is achieved using bone cement.

AI/ML Overview

1. Table of acceptance criteria and reported device performance:

Test	Acceptance Criteria (Implied)	Reported Device Performance
Range of Motion	Demonstrated performance comparable to accepted standards for knee joint prostheses.	Tests were conducted, and results demonstrated the device is safe and effective.
Contact Area and Contact Pressure on Femorotibial Joint	Demonstrated performance comparable to accepted standards for knee joint prostheses.	Tests were conducted, and results demonstrated the device is safe and effective.
Contact Area and Contact Pressure on Femoropatellar Joint	Demonstrated performance comparable to accepted standards for knee joint prostheses.	Tests were conducted, and results demonstrated the device is safe and effective.
Subluxation of Femorotibial Joint	Demonstrated resistance to unacceptable subluxation under normal physiological loads.	Tests were conducted, and results demonstrated the device is safe and effective.
Fatigue Compression Test of Femoral Component	Demonstrated durability and resistance to failure under cyclic loading conditions representative of in-vivo use, meeting established standards.	Tests were conducted, and results demonstrated the device is safe and effective.

Note: The document states that the submission was prepared in accordance with the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA." The specific quantitative acceptance criteria are not explicitly detailed in this summary but are implied to be those outlined in this guidance document.

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

Sample size for the test set: Not applicable. The "Performance Data" section explicitly states "None provided as a basis for substantial equivalence" for clinical performance data. The device's safety and effectiveness were evaluated through non-clinical (bench) testing.
Data provenance: Not applicable. No clinical data (which would have provenance) was provided.

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

Not applicable. The study relies on non-clinical performance data (bench testing) rather than clinical data requiring expert review for ground truth.

4. Adjudication method for the test set:

Not applicable. The study relies on non-clinical performance data (bench testing).

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 medical device (femoral component for knee replacement) and not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a medical device and does not involve an algorithm. The "standalone" performance here would refer to the physical device's mechanical performance, which was assessed through bench testing as described in the "Non-clinical Performance" section.

7. The type of ground truth used:

Bench Testing Standards: The ground truth for the non-clinical tests would be defined by established engineering and biomechanical standards (e.g., ASTM standards, or those referenced in the FDA's "Class II Special Controls Guidance Document") for the performance metrics being evaluated (e.g., range of motion, contact pressure, fatigue strength). The device's performance was compared against these predefined physical and mechanical thresholds for safety and effectiveness.

8. The sample size for the training set:

Not applicable. This is a medical device, not an AI model.

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

Not applicable. This is a medical device, not an AI model.

Summary

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JUN | 6 2014

U2 Femoral Component, CR, Cemented

510(k) Summary

510(k) Summary of Safety and Effectiveness

Submitter Information
Name	United Orthopedic Corporation
Address	No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan
Phone Number	+886-3-5773351 ext. 2212
Fax Number	+886-3-577156
Name of Contact Person	Fang-Yuan HoRegulation and Document Management
Date prepared	January 10, 2014
Name of Device
Trade Name	U2 Femoral Component, CR, Cemented, #7
Common Name	Femoral Component
Classification Name andRegulation	Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis under 21CFR §888. 3560
Device Class	Class II
Classification Panel	Orthopaedics
Product Code	JWH
Predicate Device	1. “United” U2 Total Knee System (K051640).2. “Smith & Nephew” Genesis II Total Knee System (K951987)

Device Description:

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U2 Femoral Component, CR, Cemented

is achieved using bone cement.

Intended Use:

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

Comparison to Predicate Device:

U2 Cemented Femoral Component-CR Type has the same materials, design, manufacturing and sterilization method as the femoral component of "United" U2 Total Knee System (K051640), except adding size #7. Besides, the basic design; size distribution, intended use of the subjected device and the method of fixation are similar with the femoral component of "Smith & Nephew" Genesis II Total Knee System (K951987).

Performance Data:

● Non-clinical Performance

This 510(k) submission was prepared in accordance with the Agency's, " Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial

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ਹੈ U2 Femoral Component, CR, Cemented

510(k) Summary

Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA". Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device, and the test results demonstrated that this device is safe and effective.

Range of Motion a.
Contact Area and Contact Pressure on Femorotibial Joint b.
Contact Area and Contact Pressure on Femoropatellar Joint c.
Subluxation of Femoroltibial Joint d.
e. Fatigue Compression Test of Femoral Component

● Clinical Performance Data/Information

None provided as a basis for substantial equivalence.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

June 16, 2014

United Orthopedic Corporation Fang-Yuan Ho Regulatory Affairs Manager Number 57, Park Avenue 2, Science Park Ksinchu 300 Taiwan

Re: K140073

Trade/Device Name: U2 Femoral Component, CR, Cemented Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 24, 2014 Received: March 25, 2014

Dear Fang-Yuan Ho:

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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Page 2 - Fang-Yuan Ho

(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 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/ResourcesforYou/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 yours.

Lori A. Wiggins

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

Enclosure

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Indication for Use

510 (k) Number (if known): K140073

Device Name: U2 Femoral Component, CR, Cemented

Indications for Use:

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

Prescription Use x AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.