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 deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device system is designed for cemented use only.

Device Description

U2 XPE Total Knee System includes U2 XPE tibial inserts and U2 XPE patellar components of a Total Knee System.

U2 XPE tibial inserts are intended to be used with the cemented U2 femoral components (K051640) and the cemented U2 tibial tray (K051640) in total knee arthroplasty. U2 XPE tibial inserts will be made in Cruciate Retaining (CR) and Posteriorly Stabilized (PS) designs.

If replacement of the articular surface of the patella is required, U2 XPE patellar components are intended to be used with any one of the "UNITED" femoral components (K021657, K051640, K082424) in total knee arthroplasty. U2 XPE patellar components are available in Onset with three pegs and Inset with one peg designs. The all polyethylene patellar components are intended for implantation with bone cement only.

The geometric design and size distribution of U2 XPE tibial inserts are identical to the previously cleared tibial inserts of U2 Total Knee System (K051640). The geometric design and size distribution of U2 XPE Onset patellar components and Inset patellar components are identical to the previously cleared U2 patellar components (K051640) and UKNEE patellar components (K021657) respectively. U2 XPE tibial inserts and patellar components are manufactured from irradiated UHMWPE which conform to ASTM F2565, while the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The manufacturing processes are identical to the predicate devices tibial inserts and patellar components (K051640, K021657), except for the addition of irradiating the polyethylene and melt annealing steps to reduce free radicals of material. The irradiated UHMWPE material has been assessed according to the tests recommended in ASTM F2759.

AI/ML Overview

The provided text describes the U2 XPE Total Knee System, a medical device. However, it does not contain specific acceptance criteria (numerical thresholds for performance) or detailed study results that demonstrate the device meets such criteria. Instead, it states that "Testing and analysis includes locking strength, range of motion and constraint, fatigue strength, wear simulation test, and materials properties of the U2 XPE Total Knee System, have been completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." This indicates that tests were performed, but the acceptance criteria met and the detailed results are not provided in this summary.

Therefore, for aspects like "Table of acceptance criteria and the reported device performance," "Sample size used for the test set," "Number of experts used to establish ground truth," and "Adjudication method," the information is not available in the provided document.

Here's what can be extracted based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Locking Strength	Testing and analysis completed; demonstrated safe and effective.
Range of Motion and Constraint	Testing and analysis completed; demonstrated safe and effective.
Fatigue Strength	Testing and analysis completed; demonstrated safe and effective.
Wear Simulation Test	Testing and analysis completed; demonstrated safe and effective.
Materials Properties	Testing and analysis completed; demonstrated safe and effective.

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

Sample Size for Test Set: Not specified.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It describes laboratory testing ("wear simulation test," "fatigue strength," etc.), rather than clinical trials with human subjects.

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

Number of Experts: Not applicable, as this refers to laboratory-based performance testing, not human-adjudicated clinical data.
Qualifications of Experts: Not applicable.

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

Not applicable, as this refers to laboratory-based performance testing, not human-adjudicated clinical data.

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:

No, an MRMC comparative effectiveness study was not done. This device is a total knee system, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This device is a total knee system, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the performance testing of this device would be defined by engineering and biomechanical standards (e.g., ASTM F2565, ASTM F648, ISO 5834, ASTM F2759), which are used to evaluate characteristics like material properties, wear, and mechanical strength. The results are compared against these predetermined specifications to ensure safety and effectiveness.

8. The sample size for the training set:

Not applicable. This device is a total knee system and its performance evaluation involves physical and mechanical testing, not a machine learning model that requires a training set.

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

Not applicable. (See #8)

Summary

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U2 XPE Total Knee System

163733 510(k) Summary

510(k) Summary of Safety and Effectiveness

Submission Information

(വ

Company:	United Orthopedic Corporation
Address:	No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan
Contact Person:	Fang-Yuan Ho,Regulatory Affairs ManagerPhone:+886-3-5773351 ext. 212Fax:+886-3-5777156
Date Prepared:	December 15, 2010

Device Identification

Device Name:	U2 XPE Total Knee System
Common Name:	Semi-constrained total knee prostheses
Classification Nameand Reference :	Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis per 21CFR 888.3560.This falls under the Orthopedics panel.
Device Product Code	JWH
Predicate Device:	1. “UNITED” U2 Total Knee system (K051640)2. “UNITED” UKNEE Total Knee System (K021657)3. “Zimmer” Prolong Highly Crosslinked Polyethylene CRArticular Surface Components (K013991)4. “Howmedica Osteonic” Scorpio X3 Tibial Bearing Insert (K071991)5. “Zimmer” NexGen Prolong All-Poly Patella (K072281)6. “Howmedica Osteonics” Scorpio X3 Patellar components (K051997)

UOC-FDA-016

Page: Summary-1/3

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U2 XPE Total Knee System

Intended Use

ਤੇ

U2 XPE 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 can be satisfactorily balanced and stabilized at the time of surgery. This device system is designed for cemented use only.

Device Description:

U2 XPE Total Knee System includes U2 XPE tibial inserts and U2 XPE patellar components of a Total Knee System.

The geometric design and size distribution of U2 XPE tibial inserts are identical to the previously cleared tibial inserts of U2 Total Knee System (K051640). The geometric

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ਹੈ U2 XPE Total Knee System

. 510(k) Summary

design and size distribution of U2 XPE Onset patellar components and Inset patellar components are identical to the previously cleared U2 patellar components (K051640) and UKNEE patellar components (K021657) respectively. U2 XPE tibial inserts and patellar components are manufactured from irradiated UHMWPE which conform to ASTM F2565, while the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The manufacturing processes are identical to the predicate devices tibial inserts and patellar components (K051640, K021657), except for the addition of irradiating the polyethylene and melt annealing steps to reduce free radicals of material. The irradiated UHMWPE material has been assessed according to the tests recommended in ASTM F2759.

Performance Data:

Testing and analysis includes locking strength, range of motion and constraint, fatigue strength, wear simulation test, and materials properties of the U2 XPE Total Knee System, have been completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.

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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 consists of a stylized eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

United Orthopedic Corporation % Mr. Fang-Yuan Ho. Regulatory Affairs Manager No. 57, Park Ave. 2, Science Park Hsinchu. 300 Taiwan

AUG - 2 2011

Re: K103733

Trade/Device Name: U2 XPE Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

Regulatory Class: II Product Code: JWH Dated: May 24, 2011 Received: June 8 2011

Dear Mr. 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

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Page 2 - Mr. Fang-Yuan Ho

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 vours.

Mark N Millican

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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Indication for Use

KI03733

510 (k) Number (if known):_

Device Name: U2 XPE Total Knee System

Indications for Use:

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 patellectorny, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery.

This device system is designed for cemented use only in the U.S.A.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

for M. Melkerson
Page 1 of 1

(Division Sign Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103733

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.