(254 days)
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.
U2 Total Knee system is the fixed bearing type with cruciate retaining and posterior stabilized design. 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 Ti alloy tibial component composed of a insert, machined from compressed molded UHMWPE flat, mechanical locked with metallic tibial baseplate. The tibial baseplate component is made of Ti-6A1-4V alloy which has groove for cement fixation. 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 1.0 +0/+0.3 mm. The patella is machined from extruded UHMWPE bar. This device have 3 pegs and cement groove designed for cemented use only.
The U2 Total Knee System is a semi-constrained knee prosthesis designed for cemented use in knee arthroplasty. The device was deemed substantially equivalent to the predicate device, the United UKNEE® Total Knee System (K021657), based on a series of comparative tests. The study was conducted by United Orthopedic Corporation in Taiwan and focused on engineering and performance characteristics relevant to total knee systems.
Here's an analysis of the acceptance criteria and study details based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Predicate Device (UKNEE® Total Knee System) Performance | U2 Total Knee System Performance | Result |
|---|---|---|---|
| Range of Motion (for daily life needs) | Not explicitly stated (implied to be sufficient) | 135° | Satisfied |
| Constraint | Baseline | Slightly more constraint than predicate device | Met/Exceeded |
| Femorotibial Joint Contact Area | Baseline | Similar or greater than predicate device | Met/Exceeded |
| Patellofemoral Joint Contact Area | Baseline | Similar or greater than predicate device | Met/Exceeded |
| Tibial Insert and Tray Locking (Anteroposterior motion at 100N load) | Baseline (implied higher motion) | Less than the predicate device | Exceeded |
| Tibial Baseplate Fatigue Properties (Cyclic Test: 200N-2.0KN, 5 million cycles) | Not explicitly stated (implied to be acceptable) | No fracture on the tibial baseplate | Satisfied |
| Beaded Porous Coating Static Tensile Strength | Not explicitly stated (implied to be acceptable) | Endured 5,000 psi min | Satisfied |
| Beaded Porous Coating Shear Strength | Not explicitly stated (implied to be acceptable) | More than 20 MPa | Satisfied |
| Beaded Porous Coating Volume Porosity | Not explicitly stated (implied to be within range) | Between 30 and 70 percent | Satisfied |
| Beaded Porous Coating Average Pore Size | Not explicitly stated (implied to be within range) | Between 100 and 1000 microns | Satisfied |
| Beaded Porous Coating Thickness | Not explicitly stated (implied to be within range) | Between 1,000 and 1,300 microns (Note: This is inconsistent. Document states "1.0 +0/+0.3 mm" which is 1000-1300 micrometers on page 1, and "1,000 and 1,300 microns" on page 3. Assuming they are referring to the same thing.) | Satisfied |
| Material Property Requirements | ASTM standards met for predicate materials | Meet the property requirements of the ASTM standards associated with each material | Satisfied |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test. The document mentions "test data" and implies a sufficient number of samples were tested to draw the stated conclusions for each performance metric (e.g., several samples for cyclic testing, contact area comparison). Given that this is a 510(k) submission for substantial equivalence based on in vitro testing, large clinical sample sizes are not typically required at this stage.
- Data Provenance: The device and testing were conducted by United Orthopedic Corporation in Taiwan. The data is retrospective in the sense that it's a submission of pre-market testing results to demonstrate substantial equivalence, rather than a prospective clinical trial with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This type of submission (510(k) for a medical device like a knee implant based on engineering and comparative testing) does not typically involve human "ground truth" established by medical experts in the same way an AI diagnostic algorithm might. The "ground truth" here is based on objective engineering measurements, ASTM standards, and comparison to a legally marketed predicate device. Therefore, the concept of "experts establishing ground truth" in the traditional sense for diagnostic accuracy doesn't apply. The engineers and scientists conducting the tests and interpreting the results, as well as the FDA reviewers, act as the "experts" in evaluating the data against established standards and predicate performance.
4. Adjudication method for the test set
- Not applicable as this is an engineering and materials testing submission, not a study involving human interpretation or clinical adjudication. The data is generated from physical and mechanical tests.
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 a study involving human readers or AI assistance. It is a pre-market submission for a physical medical device (knee implant) based on engineering performance data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm. It is a physical medical device.
7. The type of ground truth used
- The "ground truth" for this submission is primarily based on:
- Engineering specifications and measurements: Directly measured physical and mechanical properties (e.g., range of motion, force, stress, dimensions).
- ASTM standards: Adherence to established industry standards for material properties and test methods.
- Performance of the predicate device: The UKNEE® Total Knee System serves as the direct comparative benchmark, establishing what "acceptable" performance looks like for similar devices already on the market.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning study, so there is no "training set." The device design and materials are based on established engineering principles and prior knowledge of knee arthroplasty.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device submission.
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2006 MAR I
U2 Total Knee System
Summary
510(k) Summary of Safety and Effectiveness
United UKNEE® Total Knee System ( K021657 )
| 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 12, 2005 |
| Device Name: | U2 Total Knee System |
| Common Name: | Semi-constrained total knee prostheses |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis per 21CFR 888.3560This falls under the Orthopedics panel/87 |
Predicate Device:
The data that United Orthopedic Corporation included in this submission show the U2 Total Knee System (Cruciate retaining type and posterior stabilized type) is safe and effective. The U2 Total Knee System comprises a femoral component, which articulates with a polyethylene insert 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 component. 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 U2 Total Knee System performs as well or better than the predicate device in all areas tested. Materials used in the manufacture of the U2 Total Knee System meet the property requirements of the ASTM standards associated with each material.
United Orthopedic Corporation, Taiwan.
Page: 1 / III
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(S) U2 Total Knee System
Summary
Device Description:
U2 Total Knee system is the fixed bearing type with cruciate retaining and posterior stabilized It is a Patellofemorotibia, polymer/metal/polymer, semi-constrained, cemented knee design. prosthesis, which has a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component and Ti alloy tibial component composed of a insert, machined from compressed molded The tibial baseplate UHMWPE flat, mechanical locked with metallic tibial baseplate. component is made of Ti-6A1-4V alloy which has groove for cement fixation. 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 1.0 +0/+0.3 mm. The patella is machined from extruded UHMWPE bar. This device have 3 pegs and cement groove 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, 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.
Basis for Substantial Equivalence:
Features comparable to predicate devices, United UKNEE® Total Knee System ( K021657 ) , include femoral components, patellar components, tibial trays and tibial inserts. The femoral components are available in cruciate retaining and posterior stabilized designs. Tibial inserts are available in a range of thickness and in cruciate retained and posterior stabilized designs. The patellar components are available in all plastic on-set designs with dome shape configurations.
United Orthopedic Corporation, Taiwan.
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Summary
Test Results:
The U2 Total Knee System was analyzed following draft guidance for ccmented. semi-constrained total knee prostheses. The range of motion for the U2 Total Kncc System is 135°, 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 with the UKNEE® Total Knee System and showed the U2 Total Knee System to be slightly more constraint.
Contact area between the femorotibial joint and patellofemoral joint is conducted respectively, and compared with other two products, AMK® and UKNEE®. From the data, we can find U2 Total Knee System could provide similar or greater contact area than others.
Comparing the tibial insert and tibial tray locking with UKNEE®, the average anteroposterior motion at 100N load of U2 Total Knee System is less than the predicated device, which means the locking mechanism of U2 Total Knee System is stronger than UKNEE®.
Cyclic test is performed on U2 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.
The static tensile strength of the beaded porous coating was conformed to endure 5,000 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 1,000 and 1,300 microns.
Based on previous test results, the U2 Total Knee System is substantial equivalent :o UKNEE® Total Knee System.
nited Orthopedic Corporation, Taiwan.
Page: III / III
යි. පිහිටි පිහිටි පිහිටි පිහිටි විසින් පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි ප
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR I 2006
Mr. Gene Huang Regulatory Affairs Coordinator United Orthopedic Corporation No. 57, Park Ave. 2, Science Park Hsinchu 300, Taiwan
Re: K051640
Trade/Device Name: U2 Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: February 24, 2006 Received: February 27, 2006
Dear Mr. Huang:
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
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Page 2 - Mr. Gene Huang
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Heilut Lemmer us
Image /page/4/Picture/5 description: The image shows a handwritten word that appears to be "for". The word is written in a cursive style, with the letters connected. The "f" has a loop extending above the main body of the letter, and the "o" and "r" are joined together in a flowing manner. The writing is simple and clear, making the word easily readable.
Mark N. Melkerson, M.S. Acting 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): | K051640 |
|---|---|
| ---------------------------- | --------- |
Device Name: __U2 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, 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.
Prescription Use (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 OF
NEEDED)
510(k) Number.
§ 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.