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 patello femoral 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

The design of the UKNEE Total Knee System covers both of the cruciate retaining and posterior stabilized types. It is a patellofemorotibia, polymer/metal/polymer, semi-constrained, cemented knee prosthesis, which has a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component and tibial component composed of a insert, machined from compressed molded UHMWPE flat, mechanical locked with metallic tibial baseplate. There are two types of tibial baseplate component, one is one piece with grooved but without beaded porous coating and the other is modular, with and/or without beaded porous coating, locked with a keeled or round stem by means of Morse Taper. The cruciate retaining type of femoral component has w/ and w/o beaded porous coating design, and the posterior stabilized type has only w/o. The porous coating with two layers of beads has an about 55% of porosity, a 440 um of average pore size, and its thickness is 1.2 +0/+0.3 mm. The patellar components are machined from extruded UHMWPE bar and designed for cemented use only.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the UKNEE Total Knee System, based on the provided document:

UKNEE Total Knee System

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes various tests performed on the UKNEE Total Knee System and compares its performance to predicate devices. It does not explicitly state pre-defined "acceptance criteria" with numerical targets for each test, but rather presents the results and concludes that the device performs "as well or better than the predicate device in all areas tested" and is "substantial equivalent" to the predicate devices.

Here's a table summarizing the reported performance, with the understanding that "acceptance" is implicitly defined by being comparable or superior to the predicate devices:

Test / Performance Metric	Stated Acceptance Criteria (Implicit)	Reported UKNEE Total Knee System Performance	Comparison to Predicate Devices
Range of Motion	0° to 115°	0° to 115°	Satisfies "necessary needs of daily life and general activities."
Constraint	N/A (Comparative)	Slightly less constraint	Slightly less constraint than Omnifit® Total Knee System.
Femorotibial & Patellofemoral Contact Area	N/A (Comparative)	Similar or greater contact area	Similar or greater contact area than Omnifit® and AMK® (other market products).
Morse Taper Pull-off Resistance Strength	N/A (Comparative)	444 kgf	Substantial to or better than Genesis® (340 kgf).
Morse Taper Torsional Resistance Strength	N/A (Comparative)	4.56 kgf-m	Substantial to or better than Genesis® (1.44 kgf-m).
Tibial Insert & Tibial Tray Locking (Anteroposterior Motion at 100N load)	N/A (Comparative)	Average anteroposterior motion is less than the predicated device.	Stronger than &/or similar to Genesis®.
Tibial Baseplate Cyclic Fatigue	No fracture after 5M cycles	No fracture after 5 million cycles with compressive cyclic load between 200N and 2.0KN.	(No direct comparison to predicate device explicitly stated for this specific test, but implies passing the fatigue requirement)
Patellofemoral Joint Lateral Stability	N/A (Comparative)	Larger stability	Larger stability than Omnifite Total Knee System to prevent lateral dislocation.
Beaded Porous Coating Static Tensile Strength	5000 psi min.	Conformed to endure 5000 psi min.	(No direct comparison to predicate device explicitly stated)
Beaded Porous Coating Shear Strength	> 20 MPa	More than 20 MPa	(No direct comparison to predicate device explicitly stated)
Beaded Porous Coating Volume Porosity	30-70 percent	Between 30 and 70 percent	(No direct comparison to predicate device explicitly stated)
Beaded Porous Coating Average Pore Size	100-1000 microns	Between 100 and 1000 microns	(No direct comparison to predicate device explicitly stated)
Beaded Porous Coating Thickness	500-1500 microns	Between 500 and 1,500 microns. (Also mentioned: 1.2 +0/+0.3 mm, which is 1200 +0/+300 microns for a specific type)	(No direct comparison to predicate device explicitly stated)

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the sample sizes used for each of the physical tests (e.g., number of components tested for Morse taper strength, number of baseplates for cyclic fatigue). It refers to "test data," but specific N values are not provided.

The data provenance is not explicitly stated. These are in vitro mechanical engineering tests performed on the physical device components, not clinical data from patients. Therefore, terms like "country of origin of the data," "retrospective," or "prospective" are not applicable in the human clinical sense. The tests were likely conducted by the manufacturer, United Orthopedic Corporation, based in Taiwan.

3. Number of Experts and Qualifications for Ground Truth for Test Set

This section is not applicable as the document describes in vitro mechanical testing of physical implants, not diagnostic or clinical performance requiring expert ground truth.

4. Adjudication Method for the Test Set

This section is not applicable as the document describes in vitro mechanical testing of physical implants, not diagnostic or clinical performance requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study for AI

This section is not applicable. The UKNEE Total Knee System is a physical joint replacement implant (a medical device), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. Standalone (Algorithm Only) Performance

This section is not applicable. The UKNEE Total Knee System is a physical joint replacement implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance claims are the results of standardized mechanical and physical tests performed on the device components, often compared against established ASTM standards and data from predicate devices. For material properties, the ground truth is the measured property values meeting ASTM standards. For mechanical performance, the ground truth is the measured force, torque, motion, or fatigue response under specified test conditions.

8. Sample Size for the Training Set

This section is not applicable. The UKNEE Total Knee System is a physical medical device. It does not involve machine learning or AI models, and therefore does not have a "training set" in that context. The design and manufacturing process would involve engineering principles and material science, not data training.

9. How the Ground Truth for the Training Set was Established

This section is not applicable, as there is no "training set" for this type of medical device.

Summary

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K02165-7

UKNEE Total Knee System

Summarv

510(k) Summary of Safety and Effectiveness

Company:	United Orthopedic Corporation
Address:	No 57, Park Ave. 2, Science Park, Hsinchu 300, Taiwan
Phone Number:	+886-3-5773351
Fax Number:	+886-3-5777156
Date Prepared:	May 14, 2002
Device Name:	UKNEE Total Knee System
Common Name:	Semi-constrained total knee prostheses
Classification Name:	Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis per 21CFR 888.3560.This falls under the Orthopedics panel/87.
Predicate Device:	Osteonics Omnifit® Total Knee System,Kirschner Performance® Total Knee System andSmith & Nephew, Genesis® Total Knee System

The data that United Orthopedic Corporation included in this submission show the UKNEE Total Knee System (Cruciate retaining type and posterior stabilized type) is safe and effective. The UKNEE Total Knee System comprises a femoral component, which articulates with a fully polyethylene insert component. The underside of the insert component is flat and is snapped into the metal tibial component. The modular (snap-fit) locking mechanism of the insert components has proven to be safe and effective in the clinical area. The design and sizing of the femoral component correspond to the natural femoral anatomy, enhancing stress distribution and contributing to restore original femoral dimensions and normal rotation, extension and flexion. Each size of femur has the same intercondylar distance and radius of curvature; this feature is replicated on the insert component, thus allowing any size of femur to be matched with any size of tibial component. The dome shape all UHMWPE patellar design provides excellent contact and even distribution of stresses, simplifies implantation by eliminating need for rotational orientation. Test data indicate the UKNEE Total Knee System performs as well or better than the predicate device in all areas tested. Materials used in the manufacture of the UKNEE Total Knee System meet the property requirements of the ASTM standards associated with each material.

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9 UKNEE Total Knee System

Device Description:

The design of the UKNEE Total Knee System covers both of the cruciate retaining and It is a patellofemorotibia, polymer/metal/polymer, posterior stabilized types. semi-constrained, cemented knee prosthesis, which has a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component and tibial component composed of a insert, machined from compressed molded UHMWPE flat, mechanical locked with metallic tibial baseplate. There are two types of tibial baseplate component, one is one piece with grooved but without beaded porous coating and the other is modular, with and/or without beaded porous coating, locked with a keeled or round stem by means of Morse Taper. The cruciate retaining type of femoral component has w/ and w/o beaded porous coating design, and the posterior stabilized type has only w/o. The porous coating with two layers of beads has an about 55% of porosity, a 440 um of average pore size, and its thickness is 1.2 +0/+0.3 mm. The patellar components are machined from extruded UHMWPE bar and designed for cemented use only.

Intended 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 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.

Basis for Substantial Equivalence:

Features comparable to predicate devices, Kirschner Performance ® Total Knee System, Osteonics Omnifit® Total Knee System and Smith & Nephew Genesis® Total Knee System, include femoral components, patellar components, tibial inserts, tibial inserts, tibial stems and bone augmentation wedge components. These components are available with or without porous coating. The femoral components are available in cruciate retaining and posterior stabilized designs. The tibial tray components are available in fixed and modular intramedullary stem versions. Tibial inserts are available in a range of thickness and in cruciate retained and posterior stabilized designs. The modular stems are available in round and keeled types with a variety of stem lengths. The stem is assembled via the locking taper. The patellar components are available in all plastic in-set and on-set

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g UKNEE Total Knee System

designs with dome shape configurations. The bone augmentation wedges are initially cemented to the appropriate tibial component and then cemented to the prepared underlying bone.

Test Results:

The UKNEE Total Knee System was analyzed following draft guidance for cemented, semi-constrained total knee prostheses. The range of motion for the UKNEE Total Knee System is from 0 ° to 115 °, satisfying necessary needs of daily life and general activities which exclude placing the patient in condition of severe loading caused higher risk for failure of the knee replacement, such as obesity, heavy labor, active sports participation, high levels of patient activity, likelihood of falls, alcohol or drug addiction and other disabilities, as appropriate.

Constraint testing compares the Omnifit® Total Knee System and showed the UKNEE® Total Knee System to be slightly less constraint.

Contact area between the femorotibial joint and patellofemoral joint is conducted respectively, and compared with other two market products, Omnifit® and AMK®. From the data. we can find UKNEE Total Knee System could provide similar or greater contact area than others.

The Morse taper design is applied to the locking mechanism between tibial baseplate and The pull off and torsional resistance strength are 444 kgf and 4.56 kgf-m stem. respectively. When compared with Genesis®, which are 340 kgf and 1.44 kgf-m, it is substantial to or better than the predicated device.

Comparing the tibial insert and tibial tray locking testing with Genesis®, the average anteroposterior motion at 100N load of UKNEE Total Knee System is less than the predicated device, which means the locking mechanism of UKNEE Total Knee System is stronger than &/or similar to Genesis®.

Cyclic test is performed on UKNEE system to evaluate the fatigue properties of tibial baseplate. Compressive cyclic load between 200N and 2.0KN, 5 million cycles is applied to the test system. There is no fracture on the tibial baseplate.

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g UKNEE Total Knee System

The lateral stability of UKNEE Total Knee System is compared to the Omnifite Total Test results show the UKNEE knee prosthesis can provide larger stability Knee System. of patellofemoral joint to prevent lateral dislocation than Omnifit knee prosthesis.

The static tensile strength of the beaded porous coating was conformed to endure 5000 psi min.. The shear strength of the beaded porous coating was more than 20 MPa. The porous coating has volume porosity between 30 and 70 percent, an average pore size between 100 and 1000 microns and a porous coating thickness between 500 and 1,500 microns.

Based on previous test results, the UKNEE Total Knee System is substantial equivalent to Osteonics Omnifit® Total Knee System, Kirschner Performance® Total Knee System and Smith & Nephew Genesis® Total Knee System.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 2002

Mr. Philip Leung Regulatory Affairs United Orthopedic Corporation No. 57, Park Avenue 2, Science Park Hsinchu, Taiwan, Republic of China

Re: K021657

Trade/Device Name: UKnee Total Knee System 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: May 14, 2002 Received: May 20, 2002

Dear Mr. Leung:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Philip Leung

forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ Ko 2 165-7

Device Name: UKnee Total Knee System

Indications For Use:

This device system is designed for cemented use only.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 42 (Per 21 CFR 801.109)

Over-The-Counter Use No

(Optional Format 1-2-96)

Mark N Millikan

(Division Sign-Off)
Di
Ceneral Restorative
and Neurological Devices
510(k) Number. K021657

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.