This device 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 contraction. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device system is designed for cemented use only.

Device Description

The subjected device is designed for the replacement of the bearing and/or articulating surfaces of the proximal tibia composed of an articulating bearing surface fixed in a metal tibial baseplate, and is used for patients in primary or revision surgery who require augmentation and/or stem extensions due to inadequate bone stock. This premarket notification includes the following components: U2 Tibial Baseplate-CMA type, #7 Tibial Insert (CR/PS), #7 XPE Tibial Insert (CR/PS) and #7 Tibial Augment.

U2 Tibial Baseplate-CMA (Cemented Modular Augmentation) is manufactured from titanium alloy forging (ASTM F620) which is forged by titanium alloy bars (ASTM F136) with seven proportional sizes (#1 to #7). Tibial Insert and XPE insert, including PS type and CR type, is an additional size extension to the previously cleared "UNITED" U2 Total Knee System (K051640, K103733). It is manufactured from UHMWPE (ASTM F648/ISO 5834) with five available thicknesses (9, 11, 13, 15, and 18 mm). Tibial Augment is an additional size extension to the previously cleared "UNITED" U2 Total Knee System-PSA Type (K082424, K122183). It is manufactured from Ti-6Al-4V alloy (ASTM F136/ISO 5832-3) with three available thicknesses (5, 10, 15mm).

AI/ML Overview

This is a medical device 510(k) summary for the U2 Tibial Baseplate- CMA type, Tibial Insert and Augment, a semi-constrained total knee prosthesis. The document focuses on establishing substantial equivalence to predicate devices based on design, materials, manufacturing, and performance testing, rather than reporting on a study with acceptance criteria and device performance in the context of an AI/software device. Therefore, much of the requested information regarding AI device evaluation is not applicable or cannot be extracted.

However, I can provide available information based on the document's content:

1. A table of acceptance criteria and the reported device performance:

The document lists performance tests conducted, but it does not specify quantitative acceptance criteria or the numerical results from these tests. It only states that "the test results demonstrated that this device is safe and effective."

Test Category	Reported Device Performance
Locking Strength of Tibial Insert	Demonstrated device is safe and effective
Contact Area and Contact Pressure	Demonstrated device is safe and effective
Wear Simulation	Demonstrated device is safe and effective
Range of Motion	Demonstrated device is safe and effective
Fatigue Test of Tibial Baseplate	Demonstrated device is safe and effective
Fatigue Test of Tibial Insert Spine	Demonstrated device is safe and effective

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

Sample size: Not specified. The document refers to "tests" in general, but does not provide details on the number of units or conditions tested for each performance category.
Data provenance: Not applicable in the context of patient data regarding device performance. The testing pertains to the physical device components and their mechanical properties.

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

This information is not applicable as the evaluation is for a physical medical device (knee prosthesis) through mechanical testing, not an AI/software device requiring expert-established ground truth from images or other patient data.

4. Adjudication method for the test set:

Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes, not for the mechanical testing of a knee prosthesis.

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 not an AI-assisted device.

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

Not applicable. This is not an AI/software device.

7. The type of ground truth used:

Not applicable in the context of clinical "ground truth" for an AI device. For this physical medical device, the "ground truth" for the tests would be established engineering standards, material specifications (e.g., ASTM, ISO standards), and performance benchmarks for similar predicate devices.

8. The sample size for the training set:

Not applicable. This is not an AI/software device that requires a training set.

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

Not applicable. This is not an AI/software device that requires a training set.

Summary

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(9) U2 Tibial Baseplate- CMA type, Tibial Insert and Augment 510(k) Summary

510(k) Summary of Safety and Effectiveness

JAN 1 5 2014

Submitted by:	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
Date of Summary:	June 21, 2013
Contact Person	Fang-Yuan HoRegulation and Document Management
Proprietary Name:	U2 Tibial Baseplate- CMA type, Tibial Insert and Augment
Common Name:	Semi-constrained total knee prostheses
Device Classification	Knee joint patellofemorotibial polymer/metal/polymer
Name and Reference:	semi-constrained cemented prosthesis per 21CFR 888.3560.This falls under the Orthopedics panel.
Device Class	Class II
Panel Code	Orthopaedics Device
Device Product Code:	JWH
Predicate Device:	1. "UNITED" U2 Total Knee System (K051640)
	2. "UNITED" U2 XPE Total Knee System (K103733)
	3. "UNITED" U2 Total Knee System-PSA Type (K082424)
	4. "UNITED" Augment and Screw, PSA Type (K122183)
	5. "ZIMMER" NexGen Complete Knee Solution L.P.S. Flex

Device Description:

Fixed Bearing Knee (K991581)

.UOC-FDA-027

Page: 7-1/3

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(9) U2 Tibial Baseplate- CMA type, Tibial Insert and Augment 510(k) Summary

augmentation and/or stem extensions due to inadequate bone stock. This premarket notification includes the following components: U2 Tibial Baseplate-CMA type, #7 Tibial Insert (CR/PS), #7 XPE Tibial Insert (CR/PS) and #7 Tibial Augment.

Indications:

This device 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, 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 contraction. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device system is designed for cemented use only.

Basis for Substantial Equivalence:

Tibial Baseplate- CMA a.

The Tibial Baseplate- CMA has the same basic design, intended use, materials and the same manufacturing method as the tibial baseplate of the "United" U2 Total Knee System

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(9) U2 Tibial Baseplate- CMA type, Tibial Insert and Augment 510(k) Summary

and "United" U2 Total Knee System-PSA. Like the "United" U2 Total Knee System-PSA, the Tibial Baseplate- CMA can be used with extension stem and augments. Besides, the Tibial Baseplate- CMA has the same basic design, intended use, material as the tibial plate of "Zimmer" NexGen Complete Knee Solution L.P.S. Flex Fixed Knee.

Tibial Insert b.

Tibial Insert, including PS type and CR type, is an additional size extension of tibial insert of the previously cleared "UNITED" U2 Total Knee System (K051640), while the subjected XPE insert is an additional size extension of the previously cleared "UNITED" U2 XPE Total Knee System (K103733). The materials, design, manufacturing process of the tibial insert and XPE insert are identical to the cleared tibial inserts of "UNITED" U2 Total Knee System and "UNITED" U2 XPE Tibial Inset, respectively.

Tibial Augment c.

Tibial augment—screw locking is an additional size extension to the previously cleared "UNITED" U2 Total Knee System - PSA Type (K082424, K122183). The materials, design, manufacturing process of this device are identical to the cleared tibial inserts of "UNITED" U2 Total Knee System-PAS type.

Performance Data:

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.

Locking Strength of Tibial Insert a.
Contact Area and Contact Pressure b.
Wear Simulation C.
d. Range of Motion
e. Fatigue Test of Tibial Baseplate
f. Fatigue Test of Tibial Insert Spine

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

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

January 15, 2014

United Orthopedic Corporation Fang-Yuan Ho Regulatory Affairs Manager No. 57, Park Avenue 2, Science Park Hsinchu, 300 TAIWAN

Re: K131864

Trade/Device Name: U2 Tibial Baseplate-CMA type, Tibial Insert and Augment Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: December 5, 2013 Received: December 11, 2013

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 -- Fang-Yuan Ho

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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.

Sincercly yours.

Ronald和剑ean -S 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

K131864 510 (k) Number (if known):

Device Name: U2 Tibial Baseplate- CMA type, Tibial Insert and Augment

Indications for Use:

Prescription Use ___x Over-The-Counter Use AND/OR (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)

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Page 1 of 1 Page: 6-1/1

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.